FLEX-MT +

Stimulator, Muscle, Powered

EMSI

The following data is part of a premarket notification filed by Emsi with the FDA for Flex-mt +.

Pre-market Notification Details

Device IDK140467
510k NumberK140467
Device Name:FLEX-MT +
ClassificationStimulator, Muscle, Powered
Applicant EMSI 815 KING STREET STE 206 Alexandria,  VA  22314
ContactCherita James
CorrespondentCherita James
EMSI 815 KING STREET STE 206 Alexandria,  VA  22314
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-24
Decision Date2014-10-07
Summary:summary

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