FDA 510(k) Application Details - K232121

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K232121
Device Name	Wheelchair, Powered
Applicant	Ningbo Baichen Medical Devices Co., Ltd. Room 903, 666 Taikang Middle Road, Shouuhan Street, Yinzhou, Yinzhou District Ningbo CN Other 510(k) Applications for this Company
Contact	Wu Xiao Long Other 510(k) Applications for this Contact
Regulation Number	890.3860   More FDA Info for this Regulation Number
Classification Product Code	ITI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/2023
Decision Date	09/15/2023
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