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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 K113577
Model R153, R154, R155, R156
Device Name MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR
Applicant
MERITS HEALTH PRODUCTS CO., LTD.
no.18 jingke rd.
nantun dist
taichung, 
Contact steve chao
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/05/2011
Decision Date 05/08/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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