The following data is part of a premarket notification filed by Uni-patch, Inc. with the FDA for Tens/fes/nmes Electrodes.
| Device ID | K962332 |
| 510k Number | K962332 |
| Device Name: | TENS/FES/NMES ELECTRODES |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | UNI-PATCH, INC. 1313 WEST GRANT BLVD. Wabasha, MN 55981 |
| Contact | Thomas Moore |
| Correspondent | Thomas Moore UNI-PATCH, INC. 1313 WEST GRANT BLVD. Wabasha, MN 55981 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-17 |
| Decision Date | 1996-07-31 |