Showing posts with label Calmare. TENS. Show all posts
Showing posts with label Calmare. TENS. Show all posts

Friday, August 16, 2013

CTTC and CALMARE / Scrambler Therapy: The Devil's Details

Money Drain




i don't have it in me to elaborate -- and lord knows, i should not have to, if you've been following my one-person campaign against CTTC, the patent monger and soul-sucking corporate face of CALMARE / "Scrambler Therapy" -- snake oil salesman to people desperate for relief of their CRPS pain (and countless other types of neuropathic pain).

but, while finally deciding to peer over my pirate's eye bandage to see if my stocks had bottomed out since last friday (they're not doing well, darn it all), i did my usual check on under-the-counter-over-the-barrel penny stock CTTC, and found it at its usual sky-rocketing 0.16 with no shares having exchanged hands as of 3 pm.  still, knowing that there are "entrepreneurs" out there dicking around with it, day-trading on minuscule changes - a cent here, a cent there - that amount to twenty and thirty percent gains, it makes me nauseous that it's still trading at all.

out of habit, i looked to see if there was any "news" driving this cruel company's latest blandness, and lo! there was a bit of something.

they say the devil is in the details.  there is one glaring detail that caught part of one of my errant eyes!

CTTC filed another Form 10-Q on august 13th and in the meandering nonsense most would overlook in their brief historical rundown of their desiccated cardiac function, it is worth noting that the "inventor" of CALMARE therapy, Giussepe Marineo, is no longer referred to as an engineer, a doctor, a holder of a doctorate, or even as a professor - as in times past. "in times past" meaning times as recent as a month ago.

Sales of our Calmare device continue to be the major source of revenue for the Company. The Company initially acquired the exclusive, worldwide rights to the Scrambler Therapy� technology in 2007. The Company's 2007 agreement with Giuseppe Marineo ("Marineo"), the inventor of Scrambler Therapy technology, and Delta Research and Development ("Delta"), authorized CTTC to manufacture and sell worldwide the device developed from the patented Scrambler Therapy technology;
that's a pretty huge fall from grace.  no more prefixes or suffixes for poor marineo.  and many, many
questions as to previous claims and accolades about the man.

as for their raw financial news, it does cheer me.  i managed a smile on my bandaged face -- and just to drive home more about the misery of CRPS, as that's my job in life (ar ar ar!), my skin peels off with the tape holding the bandages down, and i've now several raw craters on my CRPS-afflicted face.  yes, i know, and i say it along with you -- who the hell knew it could impact the face?  and such a lovely face it once was, too.

really.

kind of cute, even.

anyway -- feast your eyes on this financial wizardry:

We incurred a net loss of $677,000 or $0.04 per basic and diluted share for the three months ended June 30, 2013, compared to a net loss of $942,000 or $0.06 per basic and diluted share for the three months ended June 30, 2012. As explained in detail below, the net loss reflects an increase of $28,000 in gross revenue, an increase of $73,000 in gross profit from product sales and a decrease in other expenses of $238,000.

oh, what the heck.  i am so weird that i enjoy meetings;  i watch school board meetings of my former school district employer;  i keep robert's rules of order at bedside for a rip-roaring good read when bored.  get ready to laugh/cry at the remaining financial assessments:


Revenue and Gross Profit from Sales
Revenue from product sales: In the three months ended June 30, 2013, we recorded $136,000 in revenue from the sale and shipment of 2 Calmare� pain therapy medical devices, with a cost of product sales of $46,000. In the three months ended June 30, 2012, we recorded $63,000 in revenue from the sale and shipment of one Calmare� pain therapy medical devices; with a cost of product sales of $45,000.
Other Revenue
Retained royalties for the three months ended June 30, 2013 were $4,000, which was $48,000 or 92% less than the $52,000 of retained royalties reported in the three months ended June 30, 2012. The 2012 amount included the receipt of a $40,000 royalty payment received for 2011 which was greater than our original estimates.
Other income for the three months ended June 30, 2013, was $10,000, including payments for training and the sale of supplies such as electrodes and cables for use with our Calmare� devices ($2,000) and rental income ($8,000) from customers who were renting Calmare� pain therapy medical devices from us. In the three months ended June 30, 2012, other income was $8,000, including payments for the sale of supplies such as electrodes and cables for use with our Calmare� devices ($5,000) and rental income ($3,000) from customers who were renting Calmare� pain therapy medical devices from us.
Expenses
Total expenses were $781,000 in the three months ended June 30, 2013, compared to $1,019,000 in the three months ended June 30, 2012, a decrease of $238,000 or 23%.
Selling expenses were $36,000 in three months ended June 30, 2013, compared to $94,000 in the three months ended June 30, 2012. The decrease of $58,000 reflects an increase of $16,000 in commission expenses due to the sale of an additional Calmare� device in 2013, which was offset by a decrease of $9,000 in domestic patent legal expenses as well as a decrease of $14,000 in foreign patent legal expenses related to the joint venture with XION Corporation to develop the melanocortin technologies combined with a decrease of $51,000 in patent and translation fees related to working with the inventor of the Calmare� device resulting from the transfer of the contractual obligation to pay patent costs back to the inventor.
Personnel and consulting expenses were $279,000 in the three months ended June 30, 2013, as compared to $502,000 in the three months ended June 30, 2012, a decrease of $223,000 or 44%. Personnel related expenses were $218,000 in the three months ended June 30, 2013, as compared to $146,000 in the three months ended June 30, 2012, an increase of $72,000 primarily due to the addition of a new CEO in November 2012, as well as the expense during the three months ended June 30, 2013 ($17,000) related to the granting of 1,000,000 options to our CEO during the three months ended March 31, 2013. No options were granted to employees in 2012. The increased personnel related expenses were offset by reductions in consulting fees ($295,000), primarily due to the termination of services related to obtaining private insurance and Medicare reimbursement approval for our Calmare medical device ($178,000) as well as the termination of the contract for the Managing Director for International Business Development ($77,000); in addition, the management services fees for our former contracted CEO ($30,000) were discontinued when the employee CEO was hired in November 2012.
General and administrative expenses were $413,000 in the three months ended June 30, 2013, a decrease of $11,000 from $424,000 in the three months ended June 30, 2012
The change reflects increases in travel expenses ($26,000) due primarily to the increased travel of the new CEO during the quarter, offset by reductions due to the departure of one nurse trainer in the three months ended June 30, 2012; increases in directors fees and expenses, including liability insurance ($8,000); increased investor and public relations expenses ($3,000); increased investment banking expenses ($3,000); increased corporate legal expenses ($3,000); increased audit and tax services fees ($6,000) both related to the timing of activities; increased marketing expenses ($7,000) and increases in postage and delivery supply expenses ($5,000). These increases were offset by reductions in legal fees associated with litigation ($38,000); rent and associated expenses due to closing the North Carolina office during 2012 ($7,000); proxy and annual meeting expenses, due to reductions in the contracted services ($8,000); financing charges ($7,000); miscellaneous expenses, banking fees, miscellaneous taxes and other fees ($4,000); depreciation expense ($1,000); and a decrease in bad debt expense due to expenses related to a former employee which were incurred in the three months ended June 30, 2012 and did not recur in 2013 ($7,000).
Interest expense was $44,000 in the three months ended June 30, 2013, compared to $13,000 in the three months ended June 30, 2012, an increase of $31,000 due to an increase in the use of debt financing.
Unrealized loss on derivative instrument of $9,000 in three months ended June 30, 2013 as compared to the $14,000 gain recorded in the three months ended June 30, 2012, reflects the difference in the portion of the Class C Preferred stock which is based on changes in the price of the Company's common shares at the end of each period (see Note 12 for details).
just slipping in under the radar is this coy little come-hither:  "At June 30, 2013, we had outstanding debt in the form of promissory notes totaling $2,630,000."  it's at this point that the 10-Q confronts the failure of its first bail out attempt:  the "Factoring Agreement with Versant Funding, LLC," according to which "Versant agreed to advance 75% of the face value to the Company, and to submit a percentage of the remainder to the Company upon collection on the account."

if you were wondering what the "news" was for this 10-Q SEC filing, i guess this is it.  Versant having seen them as crap, they've now turned to this arrangement:  "During the fourth quarter of 2012, the Company ended its Factoring Agreement with Versant and entered into a new Factoring Agreement with LSQ Funding. The Factoring Agreement with LSQ Funding provides for an 85% advance of factored accounts, lower fees, a faster payout of both advances and balances due, and the possibility of over-advances."

there is even a jovial mention of judicious use of the company's NOLs.  an NOL is something from RomneyWorld, but certainly not reflective of any corporate sense of entitlement, oh, no!
'Net Operating Loss - NOL'
A period in which a company's allowable tax deductions are greater than its taxable income, resulting in a negative taxable income. This generally occurs when a company has incurred more expenses than revenues during the period.
The net operating loss for the company can generally be used to recover past tax payments or reduce future tax payments. The reasoning behind this is that because corporations are required to pay taxes when they earn money, they also deserve some form of tax relief when they lose money.
remember that corporations are people, too.  CTTC finds itself, corporately, in something akin to the position of many red, white, and blue-hearted americans:  "At June 30, 2013, the Company's balance sheet showed cash of $24,000."

at the tail end of this sad document, probably submitted on pieced-together panels of toilet tissue to save the big bucks, CTTC pretty much announces that it probably won't make it into 2014 -- unless the miraculous therapy catches hold in some new demographic as yet to be snoockered. 

to those who continue to want giussepe marineo and CALMARE to be a valid technology, let me simply leave you with the final stage directions in this sad Everyman Medieval Play that has been performed in various chiropractors' offices and, for a still unfathomable reason, embraced by obstetricians and gynecologists... for these are the closing words of the SEC filing from tuesday:


In January 2011, the Company entered into a two-year lease effective February 1, 2011 for additional office space for the sales and training staff in Charlotte, NC. Obligations under this lease averaged $27,000 per year for the two-year term. The Company closed that office in July 2012 and closed out the lease, agreeing to forfeit the security deposit and pay the landlord a fee of $15,000 of which $9,000 remains unpaid at June 30, 2013.
please, lord, let this bilking of people in horrid pain finally cease. i picture CTTC now as a host of half-packed cardboard boxes on a utilitarian indoor-outdoor carpet with torn threads and an occasional dividing line of duct tape... in a room with flickering fluorescent lights and a dead cockroach or two in the corners.  the landlord glances in about once a week, sighs, and counts the days until he can file suit.

© 2013 L. Ryan

Friday, July 26, 2013

[updated] CALMARE / Scrambler "Therapy": Its Validity Assessed in Graphic Form

Information copied from Yahoo! Finance at time of publication.
ADDENDUM 26 July 2013:  Day traders and other yahoos are having fun with their tiny, tiny, wee little... quickie investments!  A mere 24 hours later... CTTC opened at 19!  Then plummeted to 15!  Tidy little profits for marketeers of CALMARE, made off the pain and psychological confusion of CALMARE users/proponents.  They've petitioned the SEC for more public shares.... keep the scam alinve!  Keep the scam alive!

To see all SEC filings (good reading!), click HERE.

Company Profile:
Competitive Technologies, Inc., together with its subsidiary, Vector Vision, Inc., provides patent and technology licensing and commercialization services worldwide. It identifies and commercializes technologies in life sciences, including medical testing, diagnostics, pharmaceuticals, biotechnologies, medical devices, and other medical or biological applications; physical sciences comprising chemical, display, and environmental applications; electronics, which include communications, semiconductors, Internet related, e-commerce, and consumer electronics applications; and nanotechnologies that comprise the manipulation of microscopic particles into useful arrangements and novel materials. The company commercializes technologies originally invented by individuals, corporations, and universities. It serves product inventors, manufacturers, and distributors. The company was founded in 1968 and is based in Fairfield, Connecticut.

[EMPHASIS MINE.  Recall that Giuseppe Marineo, the Italian "inventor" of CALMARE,  -- originally marketed as a treatment to increase one's "longevity" -- turned out to have falsified his CV, being neither an electrical engineer nor a professor, as claimed, but an EXCELLENT patent producer.]


Competitive Technologies Inc. (CTTC)

 -OTC Markets
0.1430 Down 0.0469(24.70%) 11:49AM EDT

Chart forCompetitive Technologies Inc. (CTTC)







Competitive Technologies Inc. (CTTC)

-OTC Markets
Prev Close:0.19
Open:0.14
Bid:N/A
Ask:N/A
1y Target Est:0.85
Beta:N/A
Next Earnings Date:N/A
Day's Range:0.1430 - 0.1430
52wk Range:0.13 - 1.04
Volume:5,000
Avg Vol (3m):29,181
Market Cap:2.34M
P/E (ttm):N/A
EPS (ttm):-0.20
Div & Yield:N/A (N/A














© 2013 L. Ryan

Tuesday, June 4, 2013

CTTC: Ask not for whom the Trolls Troll...

From InvestorsHub June 4, 2013, CTTC Chart



Too late to protect the itty-bitty minded investors in CTTC,  and all the real (non-testimonial inclined, but REAL) sufferers of severe and unrelenting neuropathic pain who were still stupid enough to pay for "treatments" with a super-duper TENS unit with extra gadgetry and a cool sounding fictive Italian provenance, treatments "personally overseen" by chiropractors and obstetricians, President Obama has announced that he's going after "patent trolls."

Upon the briefest of bleary-eyed inspection, all the CALMARE claims of "FDA approval" and "VA administration vendorship" go *poof* and turn into multicolored dried fairy turds that drift down upon us all, midst squeals of "Ew, what is that crap?"

But whatever else they've done, they've reaped the profits of their soul-sucking patents, knowing how to fill out those forms!

I'm no longer a participant in the earth-shattering dialogues taking place over at Investors Hub Competitive Technologies Inc (CTTC) Stock Message Board, where the crap flies without benefit of multi-colored, sparkly, fresh baked muffin scented fairy large intestine beautifications.  But I continue to read it, marveling at the right wing tactic adopted by the losers still defending this "company."  Lie, lie, lie, and lie again!  Fellatio in fellowship, sucking every last drop, never allowing the thought of real people, suffering, to get between the suction of their deep throats and the possibility of a few more bucks off of... not CALMARE, not "Scramber Therapy" or any other made up curative for the most difficult to treat pain dysfunctions known to medicine, from diabetic neuropathy to chemo-induced addlepating allodynia, to my personal favorite, CRPS -- no, none of that trivia.  They're sucking up the goodness of the coming dollars and euros made in strange contracts over... patent rights.  (What I don't get is why a good lawyer couldn't tear those contracts and deals apart by claiming false representation, because hasn't it been made clear, even to the most deftly daft, that Guido Marinara has misrepresented himself and his qualifications so many times that it's now a running joke?  But... Guido Marinara is something of a genius in these schemes, so he's probably avoided signing anything with his personal DNA smeared on it.  Sigh.)

French in Uproar....


I'd like to share with the evil people still supporting CTTC that I am now screaming in my sleep.  Okay, truth be told (they may need to look it up -- that's T as in Testimonial, R as in Rigmarole, U as in Unsubstantiated, and so on, ending with the big H of Hypocrisy) -- Truth be told, I've been screaming in my sleep for years, but there is a difference, qualitative and quantitative.  Now, I wake myself up as well as everyone else in The Manor, and I also require assistance to straighten my legs, turn a bit, and adjust matters so that there might be a modicum of relief.  I am unable to help myself now that my screaming has turned so bitter.  The pain tablets have to be placed in my mouth and my "Hillary for President" water bottle has to be brought to my lips.  It's humiliating, and it's scary terrifying to the people who love me.  The cats, also, are not amused, as they wish to be sole patent-holders of middle of the night caterwauling.

Anyway, from President Obama's lips and signatory pens to your investment "strategies," CTTC-ers and all your loathesome ilk:

Oh, I should say this.  It's only my theory that "patent trolling" is behind CTTC's bizarre business model.  I think it may actually have taken place -- but more in the Old Country than here in the New One.  That Italian pseudo-professor, pseudo-engineer may have out pseudo-ed a good many good old boys with a very simple scheme.

But some sort of benefit from what is essentially frivolous patenting, legal patent fraud, has to be behind CALMARE and CTTC... it cannot all be pure evil, a plot to cause those of us who scream in our sleep from pain to fork over the bucks for extra wires and knobs, chiropractors and baby-catchers.  Can it?

Is it a fluke that in the first paragraph in their forthcoming "About us" section on the CTTC website, the Founding Fathers state, clearly enough for me:

Working across a broad spectrum of disciplines and industries, CTTC provides distribution, patent and technology transfer, sales and licensing services to intellectual property owners seeking to commercialize their innovative products and technologies.

Oh, I forgot!  The company released its fascinating 2012 SEC Form10-K.  I don't know how to decipher these documents but I do recognize old-fashioned silly bullshit when it wafts before moi -- as in... compare some of these claims with the company actually doing the production of this hot product in Seoul, Korea. I did reasonably well in math, and even better in reading comprehension, back in second grade, at least, and I spotted the source of the stink unaided.  Anyway.  I am just hoping there will be some sort of prosecution here on Earth and that the FDA and the SEC don't defer everything to the Heavenly District Courts.  Nothing much approaches the level of gratuitous relief of a Balm of Gilead like indictments and public excoriation...

This article from CNNMoney was written by David Goldman [@DavidGoldmanCNN]  on June 4, 2013: 12:19 PM ET.

Obama cracks down on patent trolls


The Obama administration issued a stern rebuke of so-called "patent trolls" Tuesday, in an attempt to stop those whom the White House says manipulate the patent system for undue financial gain.


The White House directed the United States Patent and Trade Office to take five new actions that would help stem the rising tide of patent-related lawsuits tying up the court system. Many patent-holding companies with no intention of ever releasing products have made an entire business model out of suing other companies for patent infringement.



The USPTO will now require that patent-holding companies disclose who really stands to benefit from a lawsuit and identify the ultimate patent holder for each application and assigned patent. In many cases, patent-holding entities will create shell companies that allow them to hide their identities, the scope of their portfolios, and connections with other patent-holders.



The White House also wants the USPTO to train examiners to cut down on overly broad patent claims, educate small inventors about how to deal with patent trolls, and expand its outreach to inventors to help develop policies and laws.



In addition, the administration ordered a review of the U.S. International Trade Commission, which has the ability to ban imports of goods deemed to infringe on patents. Patent-holding companies are increasingly taking their claims to the ITC, and the White House would like their enforcement decisions to be made more transparent and efficient.



The Obama administration has made patent reform a priority, passing the first major overhaul of the patent system since 1952. That 2011 bill allowed the USPTO to set its own fees, gave patents to the first inventor to file a claim, and aimed to help keep some cases out of the courts. But the president clearly wants more to be done.



On a Google (GOOG, Fortune 500) Hangout in February, Obama said patent trolls abuse a system that was designed to protect inventions and foster innovation.



"They don't actually produce anything themselves," Obama said. "They're just trying to essentially leverage and hijack somebody else's idea and see if they can extort some money out of them."



Intellectual Ventures is a notorious example of a "patent troll" company. The research firm, based around the corner from Microsoft's headquarters in the Seattle area, acquires thousands of patents and has a research lab to develop its own. Yet it has no products to speak of. The company engages in constant patent litigation, and many tech companies have accused Intellectual Ventures of stifling innovation.



Intellectual Ventures said it is reviewing the administration's actions but declined comment for this story. 

The White House also asked Congress to pass laws that would have an even greater impact to curb "abusive" lawsuits. 

Among the recommendations are protections for consumers sued by patent trolls, ensuring that the ITC has flexibility to hire qualified judges, and awarding attorney's fees for court filings deemed to be "abusive."



Many technology giants have supported the administration's actions on patent reform. Tech companies are among the most-sued firms by patent trolls, and many have annual legal fees that outweigh their yearly spending on research and development. Patent lawsuits involving Apple (AAPL, Fortune 500), Samsung, Google, Oracle (ORCL, Fortune 500), Nokia (NOK), Microsoft (MSFT, Fortune 500) make daily headlines, often resulting in payouts totaling billions of dollars.



Google, whose chairman Eric Schmidt is an outspoken friend of the Obama administration, has stated that it will no longer proactively sue other companies for abuse of open-source software patents. A Google spokesman said the company welcomes the White House's actions on Tuesday.



The Association for Competitive Technology industry association, of which Microsoft, Apple, Intel (INTC, Fortune 500) and Facebook (FB) are sponsors, praised the executive actions.



"The patent system is critical to the innovation economy, but patent trolls are endangering startups around the world," said Morgan Reed, ACT's executive director, in a statement.  



Are you an entrepreneur or small business that has dealt with possible bad-faith claims of patent infringement? Email parija.bhatnagar@turner.com and you may be included in an upcoming story on CNNMoney.com.

Thursday, May 16, 2013

CALMARE / CTTC: It's important not to confuse "turds" with "money-grubbing turdified idiots"

Competitive Technologies Inc. CTTC:OTC US
Bloomberg Businessweek



One of CALMARE / CTTC 's apologists is not even trying very hard.  I feel for him/her. It calls itself "Southern Gal," a pseudo-friendly monicker that calls up trust and stand-by-your-man-shipness. On an InvestorsHub message board, s/he proudly posted the results of a study (actually ended before it had the necessary number of test subjects for statistical relevance) as if it were a GOOD thing for CALMARE "technology." Give it a quick read, with one half of your brain tied behind your back, and see what you derive as relevant information.

Let's start with what we know.  We know that Dr. Jose Ochoa is a turd, a money-driven bought mouthpiece for the insurance companies.  We hesitate to go beyond calling him a deceptive, perjuring, money-grubber turd, because he has been known to sue.

The thing is, he's not an idiot.

These CALMARE turds-for-hire?  They share his essential traits.  But... there is nothing available, as of yet, to make naming them idiots an act capable of tort-power.

Hence, until further information is disclosed, the CALMARE/Scrambler therapy advocates shall be known as "money-grubbing turdified idiots." It might be argued that their paycheck recuses them from the "idiot" category, but we are using the broadest definition of "idiot," which, in our experience includes "amoral soul suckers."


So here is the latest contribution of the Southern Belle's propagandish silliness, and any inaccuracies are hers:

A randomized, double-blind study of “Scrambler” therapy versus sham for painful chemotherapy-induced peripheral neuropathy (CIPN).  
Sub-category:
Symptom Management/Supportive Care/Palliative Care  
Category:
Patient and Survivor Care  
Meeting:
2013 ASCO Annual Meeting  
Abstract No:
9635  
Citation:
J Clin Oncol 31, 2013 (suppl; abstr 9635)  
Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2013 Annual Meeting but not presented at the Meeting, can be found online only.
Author(s): Toby Christopher Campbell, Amit J Nimunkar, Janet Retseck, Jens C. Eickhoff, Miroslav Backonja, James F. Cleary, Kristine L Kwekkeboom, Thomas Y Yen; University of Wisconsin Carbone Cancer Center, Madison, WI; University of Wisconsin, Madison, WI; University of Wisconsin Hospitals and Clinics, Madison, WI; Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI; University of Wisconsin School of Nursing, Madison, WI; University of Wisconsin Biomedical Engineering, Madison, WI
Abstract Disclosures

Abstract:
Background: CIPN is a debilitating, dose-limiting toxicity. The MC5A is a non-invasive electro-analgesia device delivering “Scrambler Therapy,” which has shown benefit for painful CIPN in uncontrolled studies. No sham-controlled trials of MC5A have been performed. Methods: Eligible patients included adults with neuropathic pain (NP) for > 6 months, pain scores =4/10 numerical rating scale (NRS), and no history of diabetes or other peripheral neuropathies. Patients received up to 10 daily sessions of 50 minutes with either MC5A or a novel active sham device constructed to deliver a just perceptible electrical sensation. Sham output is neither a TENS nor MC5A and is designed to be nontherapeutic. Active and sham treatments were applied to the affected limbs. 14 patients were randomized with no baseline differences. Patients and evaluators were blinded to study arm. Pain was measured before, daily during, after and 3 months post-treatment (verbal NRS). The primary endpoint was change in pain. Secondary endpoints included quantitative neurosensory testing (QST), validated patient-report measures, and cytokines. Results: There were 7 patients in each arm. The table shows changes in pain scores pre- and post-treatment by day and group. There was no difference between arms and no arm x day interaction. There was no significant day or arm effect for the function sub scales. Conclusions: In a small pilot study, MC5A was not significantly different from sham therapy for the primary outcome. The sham is feasible and provides a mechanism for future controlled studies with MC5A. Secondary endpoints, e.g. QST are forthcoming. Clinical trial information: NCT01261780. 


So, Dear Readers, how have you been doing?  Holding up okay?  That's right, I'm angry.  I spent a good third of the night screaming, writhing in what can only be called pain and pure misery.  Spasms, with but 10-40 seconds rest in between "sessions."  Burning limbs.  I'm gone all red, hugely edematous, a physical caricature of fire.  Oh, how I wish I had access to a machine that might provide relief that is "not significantly different from sham therapy."

Soul-sucking turdified money-grubbing idiots.  We are people in desperate pain and it's not five minutes in my "shoes" that I wish for you -- but all of my pain, in its entirety, forever.

Friday, May 6, 2011

CALMARE -- calls itself a TENS device

This is a copy of what Competitive Technologies submitted to the FDA as part of the requirement for 510(k) Premarket Notification.  I think the company's own application answers quite a few questions!


Device Classification Name:  stimulator, nerve, transcutaneous, for pain relief
Regulation Description:  Transcutaneous electrical nerve stimulator for pain relief

510(k) Number: K081255
Device Name:  SCRAMBLER ST 5 TENS DEVICE
Applicant:  COMPETITIVE TECHNOLOGIES,INC.
49 plain st.
north attleboro, MA 02760 2

Contact:  mary mcnamara
Regulation Number:  882.5890
Classification Product Code:  GZJ
Date Received:  05/02/2008
Decision Date:  02/20/2009
Decision:  substantially equivalent (SE)
Classification Advisory Committee:  Neurology
Review Advisory Committee:  Orthopedic
summary
summary
Type: Traditional
Reviewed by Third Party:  No
Expedited Review:  No

From the FDA website: 

Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA their intent to market a medical device. This is known as Premarket Notification (PMN) or 510(k). Under 510(k), before a manufacturer can market a medical device in the United States, they must demonstrate to FDA’s satisfaction that it is substantially equivalent (as safe and effective) to a device already on the market. If FDA rules the device is "substantially equivalent," the manufacturer can market the device. If the device you are researching has been in commercial distribution before 1976 or is substantially equivalent to a device already on the market, you should search FDA’s 510(k) releasable database.
So the irony is that the company claimed and was deemed, in fact, to have "substantial equivalence" to preexisting TENS devices... But now it wants to distance itself from any comparison to TENS technology. 

{snort"}