FDA 510(k) Application Details - K243110

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K243110
Device Name	Wheelchair, Powered
Applicant	SunTech UK Ltd. 25 Ormside Way, Holmethorpe Industrial Estate Rehill RH1 2LW GB Other 510(k) Applications for this Company
Contact	Jinfeng Ning 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	09/30/2024
Decision Date	05/08/2025
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