BX-400 SPORT

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-400 Sport.

Pre-market Notification Details

Device IDK813443
510k NumberK813443
Device Name:BX-400 SPORT
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 Received1981-12-09
Decision Date1982-03-08

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