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FDA 510(k) Application Details - K242402
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K242402
Device Name
Wheelchair, Powered
Applicant
Zhejiang Zhonglei Medical Technology Co.Ltd.
1st floor, 2nd floor, No. 66, Dayuan Street,
Nanmingshan Street, Liandu District
Lishui CN
Other 510(k) Applications for this Company
Contact
Chengwei Ying
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
08/13/2024
Decision Date
11/18/2024
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
FDA Source Information for K242402
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