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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K130940
Device Name KYMCO EQ20C SCOOTER
Applicant
Kwang Yang Motor Co., Ltd.
16f-2 (16a), # 462, Sec. 2, Chongde Rd.
Beitun Dist., Taichung,  TW 406
Applicant Contact JUNNATA CHANG
Correspondent
Kwang Yang Motor Co., Ltd.
16f-2 (16a), # 462, Sec. 2, Chongde Rd.
Beitun Dist., Taichung,  TW 406
Correspondent Contact JUNNATA CHANG
Regulation Number890.3800
Classification Product Code
INI  
Date Received04/04/2013
Decision Date 10/07/2013
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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