FDA 510(k) Application Details - K163125

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K163125
Device Name	Stimulator, Muscle, Powered
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	IPF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2016
Decision Date	04/10/2017
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