THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P)

Stimulator, Muscle, Powered

MYO/KINETIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Myo/kinetic Systems, Inc. with the FDA for Therapeutic Stim 200 (ts-200)/200p (ts-200p).

Pre-market Notification Details

Device IDK932399
510k NumberK932399
Device Name:THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P)
ClassificationStimulator, Muscle, Powered
Applicant MYO/KINETIC SYSTEMS, INC. N84 W13562 LEON RD. Menomonee Falls,  WI  53051
ContactHassan Hamedi
CorrespondentHassan Hamedi
MYO/KINETIC SYSTEMS, INC. N84 W13562 LEON RD. Menomonee Falls,  WI  53051
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-18
Decision Date1993-08-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.