FDA 510(k) Application Details - K113463

Device Classification Name Wheelchair, Powered

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510(K) Number K113463
Device Name Wheelchair, Powered
Applicant SUZHOU KD MEDICAL APPLIANCE CO., LTD.
16F-2(16A), NO. 462 SEC. 2
CHONGDE DR., BEITUN DIST.
TAICHUNG 406 TW
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Contact JUNNATA CHANG
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 11/22/2011
Decision Date 04/06/2012
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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