FDA 510(k) Application Details - K251285

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K251285
Device Name	Wheelchair, Powered
Applicant	Zhejiang Automwheel Tech Co., Ltd. 1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town, Wucheng District Jinhua CN Other 510(k) Applications for this Company
Contact	Zhihao Liu 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	04/25/2025
Decision Date	07/02/2025
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