NYN — Stimulator, Electrical, Transcutaneous, For Arthritis Class II
FDA product code NYN covers "Stimulator, Electrical, Transcutaneous, For Arthritis", a Class II medical device regulated under 21 CFR 882.5890. Submissions are reviewed by the Neurology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NYN
- Device Class
- Class II
- Regulation Number
- 882.5890
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K142236 | vision quest industries | BioniCare Hand System | March 23, 2015 |
| K111557 | seven seas distribtion and manufacturing | X-FORCE | November 10, 2011 |
| K073386 | pain management technologies | JOINT STIM, MODEL 1000 | July 30, 2008 |
| K062325 | rs medical | RS-4I MUSCLE STIMULATOR FAMILY | April 13, 2007 |
| K052625 | bionicare medical technologies | BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 | December 5, 2005 |
| K030332 | bionicare medical technologies | MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 | June 6, 2003 |
| K983228 | murray electronics | BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000 | March 15, 1999 |
| K971437 | murray electronics | BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000 | July 22, 1997 |