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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
Device Name MECHANICAL WHEELCHAIR
Original Applicant
AIKIN HEALTHCARE CO., LTD
5401 s. cottonwood ct.
greenwood village,  CO  80121
Original Contact kevin walls
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/04/2012
Decision Date 04/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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