FDA 510(k) Application Details - K250134

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K250134
Device Name	Wheelchair, Powered
Applicant	Ningbo Youhuan Automation Technology Co., Ltd. Room 103-24, No. 352, No. 277 Shui Street No. 756 Tiantong South Road, Yinzhou District Ningbo 315000 CN Other 510(k) Applications for this Company
Contact	Francis Xu 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	01/17/2025
Decision Date	03/26/2025
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