FDA 510(k) Application Details - K250158

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K250158
Device Name	Wheelchair, Powered
Applicant	Zhe jiang Cleisman Industry and Trade Co.,LTD Workshop No.3,Xiaoweiyuan,Dongtuo Block ll, Lishui High-tech Zone,Xinbi Street,Jinyun County Lishui CN Other 510(k) Applications for this Company
Contact	Chongjie Zheng 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	01/21/2025
Decision Date	04/28/2025
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