FDA 510(k) Application Details - K241337

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K241337
Device Name	Wheelchair, Powered
Applicant	Kunshan Hi-Fortune Health Products Co., Ltd No.625 Juxiang Road, Zhangpu Town Kunshan 215321 CN Other 510(k) Applications for this Company
Contact	Lewis Tian 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	05/13/2024
Decision Date	10/17/2024
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