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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 K153328
Device Name SUNCO Mechanical Wheelchair, model SKW-9003
Applicant
Danyang Sunco Machinery Co., Ltd.
Taojing Rd., Optics Industrial Park, Situ Town
Danyang City,  CN 212300
Applicant Contact JEN KE-MIN
Correspondent
Danyang Sunco Machinery Co., Ltd.
Taojing Rd., Optics Industrial Park, Situ Town
Danyang City,  CN 212300
Correspondent Contact JEN KE-MIN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received11/19/2015
Decision Date 07/20/2016
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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