FDA 510(k) Application Details - K192161

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K192161
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Fast Fit LLC 450 Park Avenue 31st Floor New York, NY 10022 US Other 510(k) Applications for this Company
Contact	Lisa Falcone Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	NGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2019
Decision Date	01/22/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review