K861399Substantially Equivalent

Powerstim Electronic Muscle Stimulator

Name: K861399 Powerstim Electronic Muscle Stimulator
Creator: Bio-Med Systems Corp.
Published: 1986-06-17
License: https://open.fda.gov/license/

Bio-Med Systems Corp., Ontario, Toronto, CA / Traditional, Substantially Equivalent

FDA source

K861399 is the FDA 510(k) clearance record for POWERSTIM ELECTRONIC MUSCLE STIMULATOR, cleared for Bio-Med Systems Corp. on 1986-06-17. FDA records list one 510(k) clearance for Bio-Med Systems Corp. As of 2026-09-10, FDA records show no recalls naming K861399.

Clearance record

Decision date: 1986-06-17
Received: 1986-04-15 (63 days to decision)
Review panel: Unknown
Applicant: Bio-Med Systems Corp. 1560 Yonge St., Ontario, Toronto, CA
Third party review: No