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
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.