BX-600 EMS

Stimulator, Muscle, Powered

BLOOMEX INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Bloomex International, Inc. with the FDA for Bx-600 Ems.

Pre-market Notification Details

Device IDK832976
510k NumberK832976
Device Name:BX-600 EMS
ClassificationStimulator, Muscle, Powered
Applicant BLOOMEX INTERNATIONAL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-02
Decision Date1983-11-25

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