FDA 510(k) Application Details - K132179

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K132179
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	ION GENIUS INC 1833 KALAKAUA AVE. HONOLULU, HI 96801 US Other 510(k) Applications for this Company
Contact	XANYA SOFRA-WEISS, PH.D 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	07/15/2013
Decision Date	04/28/2014
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