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 |