The following data is part of a premarket notification filed by Uni-patch, Inc. with the FDA for Spec T.e.n.s. Prewired Repositionable Tens Electrode - Modify.
| Device ID | K962910 |
| 510k Number | K962910 |
| Device Name: | SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | UNI-PATCH, INC. P.O. BOX 271 1313 WEST GRANT BLVD. Wabasha, MN 55981 -0271 |
| Contact | Thomas O Moore |
| Correspondent | Thomas O Moore UNI-PATCH, INC. P.O. BOX 271 1313 WEST GRANT BLVD. Wabasha, MN 55981 -0271 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-05 |
| Decision Date | 1996-09-05 |
| Summary: | summary |