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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K113463
Device Name POWER WHEELCHAIR
Applicant
Suzhou KD Medical Appliance Co., Ltd.
16f-2(16a), # 462 Sec. 2
Chongde Dr., Beitun Dist.
Taichung,  TW 406
Applicant Contact JUNNATA CHANG
Correspondent
Suzhou KD Medical Appliance Co., Ltd.
16f-2(16a), # 462 Sec. 2
Chongde Dr., Beitun Dist.
Taichung,  TW 406
Correspondent Contact JUNNATA CHANG
Regulation Number890.3860
Classification Product Code
ITI  
Date Received11/22/2011
Decision Date 04/06/2012
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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