The following data is part of a premarket notification filed by Physio Technology, Inc. with the FDA for Automove/omnistim Iv-electrical Muscle Stimulator.
| Device ID | K850850 |
| 510k Number | K850850 |
| Device Name: | AUTOMOVE/OMNISTIM IV-ELECTRICAL MUSCLE STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | PHYSIO TECHNOLOGY, INC. 1925 W. 6TH ST. Topeka, KS 66606 |
| Contact | James G Baumann |
| Correspondent | James G Baumann PHYSIO TECHNOLOGY, INC. 1925 W. 6TH ST. Topeka, KS 66606 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-01 |
| Decision Date | 1985-07-01 |