The following data is part of a premarket notification filed by Myo-tronics Research, Inc. with the FDA for Electric Muscle Stimulator.
| Device ID | K813533 |
| 510k Number | K813533 |
| Device Name: | ELECTRIC MUSCLE STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | MYO-TRONICS RESEARCH, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-17 |
| Decision Date | 1982-03-05 |