The following data is part of a premarket notification filed by Uni-patch, Inc. with the FDA for Tens/fes/nmes Electrodes.
| Device ID | K983097 |
| 510k Number | K983097 |
| Device Name: | TENS/FES/NMES ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | UNI-PATCH, INC. P.O. BOX 271 1313 WEST GRANT BLVD. Wabasha, MN 55981 -0271 |
| Contact | Manager J Geolat |
| Correspondent | Manager J Geolat UNI-PATCH, INC. P.O. BOX 271 1313 WEST GRANT BLVD. Wabasha, MN 55981 -0271 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-24 |
| Decision Date | 1999-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B312C5020PF0 | K983097 | 000 |
| B312C5010PF0 | K983097 | 000 |