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FDA 510(k) Application Details - K242560
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K242560
Device Name
Wheelchair, Mechanical
Applicant
Foshan Shunkangda Medical Tech Co., Ltd.
Pingnan Industrial Area, Guicheng Nanhai District,
Foshan City, Guangdong, CN.
Foshan CN
Other 510(k) Applications for this Company
Contact
Ruizhuo Xu
Other 510(k) Applications for this Contact
Regulation Number
890.3850
More FDA Info for this Regulation Number
Classification Product Code
IOR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/28/2024
Decision Date
10/24/2024
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 K242560
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