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FDA 510(k) Application Details - K240673
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K240673
Device Name
Wheelchair, Powered
Applicant
Zhejiang Hfizer Medical Equipment CO.,LTD.
No.7, Yunliu Road, Baiyun Industrial Zone, Jiangnan Street,
Yongkang City, Zhejiang Province
Yongkang CN
Other 510(k) Applications for this Company
Contact
Ken Hu
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
03/11/2024
Decision Date
06/20/2024
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 K240673
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