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FDA 510(k) Application Details - K132257
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K132257
Device Name
Wheelchair, Mechanical
Applicant
ZHEJIANG JIAFENG ELECTRICAL & MECHANIAL CO., LTD
5 CAREY STREET
PENNINGTON, NJ 08534 US
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Contact
CHARLES SHEN
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
07/19/2013
Decision Date
02/13/2014
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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