FDA 510(k) Application Details - K243440

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K243440
Device Name	Wheelchair, Powered
Applicant	Yongkang Hengyi Vehicle Co.,Ltd No.225 Xishan Road , Dongcheng Street Yongkang CN Other 510(k) Applications for this Company
Contact	Kathyrn 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	11/06/2024
Decision Date	12/19/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review