The following data is part of a premarket notification filed by Uni-patch, Inc. with the FDA for Easy Flex Tens/fes/mns Electrodes 2 Round Model 8200/2x2 Model 8220.
| Device ID | K961141 |
| 510k Number | K961141 |
| Device Name: | EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220 |
| Classification | Electrode, Cutaneous |
| 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 | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-21 |
| Decision Date | 1996-05-10 |
| Summary: | summary |