FDA 510(k) Application Details - K112948

Device Classification Name	Wheelchair, Mechanical   More FDA Info for this Device
510(K) Number	K112948
Device Name	Wheelchair, Mechanical
Applicant	JIANGSU HEALTHY WAY MEDICAL EQUIPMENT CO;LTD INDUSTRIAL RESEARCH SOCIETY NO.58 FU CHUN ST. HSIN CHU CITY 30067 TW Other 510(k) Applications for this Company
Contact	JEN KE-MIN 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	10/04/2011
Decision Date	03/28/2012
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