FDA 510(k) Application Details - K201461

Device Classification Name	Wheelchair, Mechanical   More FDA Info for this Device
510(K) Number	K201461
Device Name	Wheelchair, Mechanical
Applicant	Ningbo Shenyu Medical Equipment Co., Ltd. No. 1318 West of Tanjialing Road Yuyao 315408 CN Other 510(k) Applications for this Company
Contact	Zhou Yuefeng 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	06/02/2020
Decision Date	05/21/2021
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