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FDA 510(k) Application Details - K223393
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K223393
Device Name
Wheelchair, Powered
Applicant
Shanghai BangBang Robotics Co., Ltd.
Room 501, Building 3, No.188 Zhongchen Road
Songjiang District
Shanghai 201613 CN
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Contact
Canfeng Liu
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
11/08/2022
Decision Date
03/16/2023
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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