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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wheelchair, powered
510(k) Number K122357
Model P322
Device Name MERITS MODEL P322FWD POWERED WHEELCHAIR
Original Applicant
MERITS HEALTH PRODUCTS CO., LTD.
no.18 jingke rd.
nantun dist
taichung,  TW 40852
Original Contact steve chao
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/03/2012
Decision Date 01/09/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Physical Medicine
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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