FDA 510(k) Application Details - K131222

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K131222
Device Name	Stimulator, Muscle, Powered
Applicant	AMPCARE, LLC 1201 RICHARDSON DRIVE SUITE 280 RICHARDSON, TX 75080 US Other 510(k) Applications for this Company
Contact	DIANE RUTHERFORD 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	04/30/2013
Decision Date	10/31/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review