Miha Bodytec II

Stimulator, Muscle, Powered, For Muscle Conditioning

Miha Bodytec Gmbh

The following data is part of a premarket notification filed by Miha Bodytec Gmbh with the FDA for Miha Bodytec Ii.

Pre-market Notification Details

Device IDK201975
510k NumberK201975
Device Name:Miha Bodytec II
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Miha Bodytec Gmbh Siemensstr. 1 Gersthofen,  DE 86368
ContactFelix Schweigert
CorrespondentFelix Schweigert
Miha Bodytec Gmbh Siemensstr. 1 Gersthofen,  DE 86368
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-16
Decision Date2021-03-11

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