FDA 510(k) Application Details - K142055

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K142055
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	WELL BRAIN INTERNATIONAL, LTD. ROOM 03, 14/F, FOOK YIP BLG., 53-57 KWAI FUNG CRESCENT KWAI CHUNG, N.T. HK Other 510(k) Applications for this Company
Contact	VICTOR K WAI 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	07/29/2014
Decision Date	05/11/2015
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