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FDA 510(k) Application Details - K170787
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K170787
Device Name
Wheelchair, Powered
Applicant
Nanjing Jin Bai He Medical Apparatus Co., Ltd.
No. 61 Qinhuai Road, Jiangning Economic and Technological
Development Zone
Nanjing 211106 CN
Other 510(k) Applications for this Company
Contact
Jen Ke-Min
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
03/16/2017
Decision Date
08/09/2017
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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