The following data is part of a premarket notification filed by Uni-patch, Inc. with the FDA for Tantone Multi-day #633 Tens Electrode.
| Device ID | K871222 |
| 510k Number | K871222 |
| Device Name: | TANTONE MULTI-DAY #633 TENS ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | UNI-PATCH, INC. P.O. BOX 271 1313 WEST GRANT BLVD. Wabasha, MN 55981 -0271 |
| Contact | Peter B Ochsner |
| Correspondent | Peter B Ochsner 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 | 1987-03-27 |
| Decision Date | 1987-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857771003811 | K871222 | 000 |
| 00857771003804 | K871222 | 000 |
| 00857771003309 | K871222 | 000 |