The following data is part of a premarket notification filed by Physio Technology, Inc. with the FDA for Modified Omnistim(tm) Electrical Muscle Stimulator.
| Device ID | K874076 |
| 510k Number | K874076 |
| Device Name: | MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | PHYSIO TECHNOLOGY, INC. 1925 W. 6TH ST. Topeka, KS 66606 |
| Contact | J. C Castel |
| Correspondent | J. C Castel PHYSIO TECHNOLOGY, INC. 1925 W. 6TH ST. Topeka, KS 66606 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-06 |
| Decision Date | 1988-01-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858703006016 | K874076 | 000 |