FDA 510(k) Application Details - K062309

Device Classification Name	Wheelchair, Mechanical   More FDA Info for this Device
510(K) Number	K062309
Device Name	Wheelchair, Mechanical
Applicant	KARMA MEDICAL PRODUCTS CO., LTD. NO. 58, FU-CHIUN ST. HSIN-CHU CITY 300 TW Other 510(k) Applications for this Company
Contact	Ke-Min Jen Other 510(k) Applications for this Contact
Regulation Number	890.3850   More FDA Info for this Regulation Number
Classification Product Code	IOR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2006
Decision Date	10/10/2006
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