The following data is part of a premarket notification filed by Physio Technology, Inc. with the FDA for Omnisound(tm) 3000.
| Device ID | K883893 |
| 510k Number | K883893 |
| Device Name: | OMNISOUND(TM) 3000 |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | PHYSIO TECHNOLOGY, INC. 1925 W. 6TH ST. Topeka, KS 66606 |
| Contact | Michael R Ronayne |
| Correspondent | Michael R Ronayne PHYSIO TECHNOLOGY, INC. 1925 W. 6TH ST. Topeka, KS 66606 |
| Product Code | IMG |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-14 |
| Decision Date | 1988-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858703006006 | K883893 | 000 |