The following data is part of a premarket notification filed by Tenscare Ltd with the FDA for Tenscare Itouch Model(s) Easy And Plus.
| Device ID | K082377 |
| 510k Number | K082377 |
| Device Name: | TENSCARE ITOUCH MODEL(S) EASY AND PLUS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | TENSCARE LTD 9 BLENHEIM ROAD Epsom, GB Kt19 9be |
| Contact | Anthony Jankel |
| Correspondent | Anthony Jankel TENSCARE LTD 9 BLENHEIM ROAD Epsom, GB Kt19 9be |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-18 |
| Decision Date | 2009-02-09 |
| Summary: | summary |