The following data is part of a premarket notification filed by Selective Med Components, Inc. with the FDA for Guardian Disposable Tens And Tens/nmes Electrodes.
| Device ID | K945676 |
| 510k Number | K945676 |
| Device Name: | GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | SELECTIVE MED COMPONENTS, INC. 208 W. HIGH ST. Mt. Vernon, OH 43050 |
| Contact | Richard J Fisher, Jr |
| Correspondent | Richard J Fisher, Jr SELECTIVE MED COMPONENTS, INC. 208 W. HIGH ST. Mt. Vernon, OH 43050 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-18 |
| Decision Date | 1995-01-30 |