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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K192161
Device Name FastFit EMS System
Fast Fit LLC
450 Park Avenue 31st Floor
New York,  NY  10022
Applicant Contact Lisa Falcone
Biologics and Medical Device Consulting Group
20370 Skyhawk Lane
Topanga,  CA  90290
Correspondent Contact Sigi Caron
Regulation Number890.5850
Classification Product Code
Date Received08/09/2019
Decision Date 01/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No