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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 K112816
Device Name ZHENJIANG ASURE MECHANICAL WHEELCHAIR
Applicant
Zhenjiang Assure Medical Equipment Co., Ltd.
# Fu Chiun St.
Hsin Chu City,  TW 30067
Applicant Contact JEN KE-MIN
Correspondent
Zhenjiang Assure Medical Equipment Co., Ltd.
# Fu Chiun St.
Hsin Chu City,  TW 30067
Correspondent Contact JEN KE-MIN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/28/2011
Decision Date 04/18/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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