FDA 510(k) Application Details - K250758

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K250758
Device Name	Wheelchair, Powered
Applicant	CHANGSHU PINGFANG WHEELCHAIR CO., LTD No.3 Ziqiang Road, Shanghu Town, Changshu Suzhou CN Other 510(k) Applications for this Company
Contact	Jian Zhu 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	03/13/2025
Decision Date	05/09/2025
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