FDA 510(k) Application Details - K123158

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K123158
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	ION GENIUS INC 7192 KALANIANAOLE HWY #D-204A HONOLULU, HI 96821 US Other 510(k) Applications for this Company
Contact	XANYA SOFRA-WEISS 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	10/09/2012
Decision Date	06/21/2013
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