FDA 510(k) Application Details - K181795

Device Classification Name	Wheelchair, Mechanical   More FDA Info for this Device
510(K) Number	K181795
Device Name	Wheelchair, Mechanical
Applicant	Sichuan AST Medical Equipment Co., Ltd. No.58, Jin-Peng Road, C Area, Luxian Industrial Park Luzhou City 646100 CN Other 510(k) Applications for this Company
Contact	Johnson Van 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	07/05/2018
Decision Date	09/25/2018
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