NEUROMUSCULAR STIMULATOR

Stimulator, Nerve, Transcutaneous, For Pain Relief

MYO/KINETIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Myo/kinetic Systems, Inc. with the FDA for Neuromuscular Stimulator.

Pre-market Notification Details

Device IDK932611
510k NumberK932611
Device Name:NEUROMUSCULAR STIMULATOR
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
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 CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-28
Decision Date1994-01-31

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