NuEra Tight Family, EMS Model

Stimulator, Muscle, Powered, For Muscle Conditioning

Bios S.r.l.

The following data is part of a premarket notification filed by Bios S.r.l. with the FDA for Nuera Tight Family, Ems Model.

Pre-market Notification Details

Device IDK201239
510k NumberK201239
Device Name:NuEra Tight Family, EMS Model
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Bios S.r.l. Via Guido Rossa 10/12 Vimodrone,  IT 20090
ContactMaurizio Bianchi
CorrespondentMaurizio Bianchi
Bios S.r.l. Via Guido Rossa 10/12 Vimodrone,  IT 20090
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-07
Decision Date2020-12-31

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