The following data is part of a premarket notification filed by Physio Technology, Inc. with the FDA for Omnistim Iii Interferential Therapy.
| Device ID | K841278 |
| 510k Number | K841278 |
| Device Name: | OMNISTIM III INTERFERENTIAL THERAPY |
| Classification | Stimulator, Muscle, Powered |
| Applicant | PHYSIO TECHNOLOGY, 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 | 1984-03-28 |
| Decision Date | 1984-04-24 |