FDA 510(k) Application Details - K180279

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K180279
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Home Skinovations Ltd. Tabor Building, Shaar Yokneam Yoqneam Illit 2069200 IL Other 510(k) Applications for this Company
Contact	Amit Goren 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	01/31/2018
Decision Date	05/09/2018
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