COMPLY NEUROMUSCULAR STIMULATOR

Stimulator, Muscle, Powered

OMEGA-MED INTL., INC.

The following data is part of a premarket notification filed by Omega-med Intl., Inc. with the FDA for Comply Neuromuscular Stimulator.

Pre-market Notification Details

Device IDK822284
510k NumberK822284
Device Name:COMPLY NEUROMUSCULAR STIMULATOR
ClassificationStimulator, Muscle, Powered
Applicant OMEGA-MED INTL., INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-07-30
Decision Date1982-09-17

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