SPARKS, Md., June 14 /PRNewswire/ -- Today, the FDA issued documents making official changes in response to BioniCare’s request for a clarification of classification for their proprietary BioniCare pulsed electrical stimulator technology. The new classification will be “Transcutaneous Electrical Stimulator for Arthritis” (T.E.S.A). BioniCare has a distinct FDA labeling for both osteoarthritis (OA) of the knee and rheumatoid arthritis (RA) of the hand based on the clinical studies, however it had been classified as a TENS based on the similar safety profile. The FDA revised all clearances for BioniCare. This change in product code will apply retroactively to all commercially available products from BioniCare: OA Knee Device and RA Hand Device. This news comes just a few months after Medicare created a new product code effective in January 2006, E0762, as a result of BioniCare’s application submission last year.
