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 |