FDA 510(k) Application Details - K123642

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K123642
Device Name	Stimulator, Muscle, Powered
Applicant	NIVEUS MEDICAL, INC. 1171 BARROILHET DRIVE HILLSBOROUGH, CA 94010 US Other 510(k) Applications for this Company
Contact	CINDY DOMECUS, R.A.C. (US & EU) 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	11/26/2012
Decision Date	03/29/2013
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