FDA 510(k) Application Details - K202148

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K202148
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Fit-Pro Ltd. 7 Szabadsag Ter Budapest 1054 HU Other 510(k) Applications for this Company
Contact	Janos Papp 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	08/03/2020
Decision Date	08/25/2021
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