FDA 510(k) Application Details - K034005

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K034005
Device Name	Stimulator, Muscle, Powered
Applicant	SKYLARK DEVICE & SYSTEMS CO., LTD 4F, 34, SEC. 3, CHUNG SHAN NORTH RD. TAIPEI 104 TW Other 510(k) Applications for this Company
Contact	GEORGE CHIANG 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	12/24/2003
Decision Date	11/18/2004
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