The following data is part of a premarket notification filed by Physio Technology, Inc. with the FDA for Omnivac (vacuum Electrode System).
| Device ID | K861039 |
| 510k Number | K861039 |
| Device Name: | OMNIVAC (VACUUM ELECTRODE SYSTEM) |
| Classification | Interferential Current Therapy |
| Applicant | PHYSIO TECHNOLOGY, INC. 1925 W. 6TH ST. Topeka, KS 66606 |
| Contact | James Baumann |
| Correspondent | James Baumann PHYSIO TECHNOLOGY, INC. 1925 W. 6TH ST. Topeka, KS 66606 |
| Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-18 |
| Decision Date | 1986-09-26 |