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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wheelchair, mechanical
510(K) Number K120032
Model AE-604M
Device Name MECHANICAL WHEELCHAIR
Applicant
AIKIN HEALTHCARE CO., LTD
5401 s. cottonwood ct.
greenwood village,  CO  80121
Contact kevin walls
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/04/2012
Decision Date 04/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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