The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Polyhesive R Electrodes/tens Muscle Stim Elec Ther.
| Device ID | K863035 |
| 510k Number | K863035 |
| Device Name: | POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER |
| Classification | Electrode, Cutaneous |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Peggy Walline |
| Correspondent | Peggy Walline VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-11 |
| Decision Date | 1986-09-18 |