The following data is part of a premarket notification filed by Physio Technology, Inc. with the FDA for Omnisound Therapy Unit.
| Device ID | K843372 |
| 510k Number | K843372 |
| Device Name: | OMNISOUND THERAPY UNIT |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | PHYSIO TECHNOLOGY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-28 |
| Decision Date | 1984-09-18 |