FDA 510(k) Application Details - K162328

Device Classification Name	Wheelchair, Mechanical   More FDA Info for this Device
510(K) Number	K162328
Device Name	Wheelchair, Mechanical
Applicant	Winner SG Pte Ltd 14 Little Road #07-01 Tropical Industrial Building Singapore 536987 SG Other 510(k) Applications for this Company
Contact	Michael Pang 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	08/19/2016
Decision Date	05/11/2017
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