THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P)

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 Stimulator 300(ts-300) & 300p(ts-300p).

Pre-market Notification Details

Device IDK932764
510k NumberK932764
Device Name:THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P)
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 Received1993-06-08
Decision Date1993-10-01

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