ELECTRONIC MUSCLE EXERCISER

Stimulator, Muscle, Powered

BLOOMEX INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Bloomex International, Inc. with the FDA for Electronic Muscle Exerciser.

Pre-market Notification Details

Device IDK821110
510k NumberK821110
Device Name:ELECTRONIC MUSCLE EXERCISER
ClassificationStimulator, Muscle, Powered
Applicant BLOOMEX INTERNATIONAL, 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 Received1982-04-20
Decision Date1982-07-01

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