FDA 510(k) Application Details - K122357

Device Classification Name Wheelchair, Powered

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510(K) Number K122357
Device Name Wheelchair, Powered
Applicant MERITS HEALTH PRODUCTS CO., LTD.
NO.18 JINGKE RD.
NANTUN DIST
TAICHUNG 40852 TW
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Contact STEVE CHAO
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 08/03/2012
Decision Date 01/09/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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