FDA 510(k) Application Details - K201131

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K201131
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Firstkind Limited Hawk House, Peregrine Business Park High Wycombe HP13 7DL GB Other 510(k) Applications for this Company
Contact	Neil Buckley 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	04/28/2020
Decision Date	05/28/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review