FDA 510(k) Application Details - K191105

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K191105
Device Name	Wheelchair, Powered
Applicant	Golden Motor Technology Co., Ltd. Room 1401-1405, Tower 5 No. 18-50 Middle Changwu Road Changzhou 213164 CN Other 510(k) Applications for this Company
Contact	Philip Yao 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	04/25/2019
Decision Date	01/21/2022
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