FDA 510(k) Application Details - K011913

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K011913
Device Name	Stimulator, Muscle, Powered
Applicant	SUN-RAIN SYSTEM CORP. NO. 58, FU-CHIUN ST. HSIN-CHU CITY TW Other 510(k) Applications for this Company
Contact	YANG TIEN-HISING 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	06/19/2001
Decision Date	10/26/2001
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