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FDA 510(k) Application Details - K212854
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K212854
Device Name
Wheelchair, Powered
Applicant
Zhejiang Qianxi Vehicle Co., Ltd.
No.366, Kechuang Road
Yongkang City 322000 CN
Other 510(k) Applications for this Company
Contact
Ada Zhang
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
09/08/2021
Decision Date
01/10/2022
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
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