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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 K101999
Device Name KAIYANG STEEL WHEELCHAIR
Applicant
Guangdong Kaiyang Medical Technology Co., Ltd.
Yanfeng Industrial Area, Dali,
Nanhai District
Foshan,  CN 528231
Applicant Contact JEN KE-MIN
Correspondent
Guangdong Kaiyang Medical Technology Co., Ltd.
Yanfeng Industrial Area, Dali,
Nanhai District
Foshan,  CN 528231
Correspondent Contact JEN KE-MIN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received07/15/2010
Decision Date 10/04/2010
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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