FDA 510(k) Application Details - K200978

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K200978
Device Name	Wheelchair, Powered
Applicant	Dongguan Prestige Sporting Goods Co., Ltd. 3rd Ind. District, Qiaotou Area, Houjie Town Dongguan 523950 CN Other 510(k) Applications for this Company
Contact	Zhang Zhao 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	04/13/2020
Decision Date	04/16/2021
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