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FDA 510(k) Application Details - K240638
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K240638
Device Name
Wheelchair, Powered
Applicant
Ningbo Youhuan Automation Technology Co., Ltd.
Room 103-24, No. 352, No. 277 Shui Street
No. 756 Tiantong South Road, Yinzhou District
Ningbo 315100 CN
Other 510(k) Applications for this Company
Contact
Francis Xu
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
03/06/2024
Decision Date
09/16/2024
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
FDA Source Information for K240638
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