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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 K072630
Device Name FORU, MODEL EQ30
Applicant
Kwang Yang Motor Co., Ltd.
14f-2, # 1, Zhuangjing Rd.
Ln. 25
Banqiao,  TW 220
Applicant Contact JUANNATA CHANG
Correspondent
Kwang Yang Motor Co., Ltd.
14f-2, # 1, Zhuangjing Rd.
Ln. 25
Banqiao,  TW 220
Correspondent Contact JUANNATA CHANG
Regulation Number890.3800
Classification Product Code
INI  
Date Received09/18/2007
Decision Date 10/03/2007
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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