The following data is part of a premarket notification filed by Staodynamics, Inc. with the FDA for Electrical Muscle Stimulator (ems).
| Device ID | K800068 |
| 510k Number | K800068 |
| Device Name: | ELECTRICAL MUSCLE STIMULATOR (EMS) |
| Classification | Stimulator, Muscle, Powered |
| Applicant | STAODYNAMICS, 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 | 1980-01-11 |
| Decision Date | 1980-02-05 |