FDA 510(k) Application Details - K242791

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K242791
Device Name	Wheelchair, Powered
Applicant	Zhejiang Kairui Medical Device Co., Ltd. No.85, Dengyun Road, Tangxia Town Ruian CN Other 510(k) Applications for this Company
Contact	Kevin Ni 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	09/16/2024
Decision Date	11/12/2024
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