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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 K081133
Device Name KYMCO FORU, MODEL EQ40
Applicant
Kwang Yang Motor Co., Ltd.
14f-2, # 1, Zhuangjing Rd.
Ln. 25
Banqiao,  TW 220
Applicant Contact JUNNATA CHANG
Correspondent
Kwang Yang Motor Co., Ltd.
14f-2, # 1, Zhuangjing Rd.
Ln. 25
Banqiao,  TW 220
Correspondent Contact JUNNATA CHANG
Regulation Number890.3800
Classification Product Code
INI  
Date Received04/21/2008
Decision Date 06/10/2008
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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