FastFit EMS System

Stimulator, Muscle, Powered, For Muscle Conditioning

Fast Fit LLC

The following data is part of a premarket notification filed by Fast Fit Llc with the FDA for Fastfit Ems System.

Pre-market Notification Details

Device IDK192161
510k NumberK192161
Device Name:FastFit EMS System
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Fast Fit LLC 450 Park Avenue 31st Floor New York,  NY  10022
ContactLisa Falcone
CorrespondentSigi Caron
Biologics And Medical Device Consulting Group 20370 Skyhawk Lane Topanga,  CA  90290
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyPhysical Medicine
510k Review PanelPhysical Medicine
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-09
Decision Date2020-01-22

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