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FDA 510(k) Application Details - K200857
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K200857
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
04/01/2020
Decision Date
12/17/2020
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
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