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FDA 510(k) Application Details - K213790
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K213790
Device Name
Wheelchair, Mechanical
Applicant
Mobility Source Medical Technology Co., Ltd.
160 Heheng Road, Yanghe Town
Gaoming District, Foshan City 528513 CN
Other 510(k) Applications for this Company
Contact
Evan Wong
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
12/06/2021
Decision Date
03/14/2022
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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