FDA 510(k) Application Details - K250475

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K250475
Device Name	Wheelchair, Powered
Applicant	NINGBO BAICHEN MEDICAL DEVICES CO., LTD Room 2101, No.666 Taikang Middle Road, Yinzhou District Ningbo 315000 CN Other 510(k) Applications for this Company
Contact	Xiaolong Wu 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	02/19/2025
Decision Date	05/27/2025
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