FDA 510(k) Application Details - K132257

Device Classification Name Wheelchair, Mechanical

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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
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Regulation Number 890.3850

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Classification Product Code IOR
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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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