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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 K062676
Device Name RUIKE, MODEL 3331
Applicant
Shanghai Ruike Sports Goods Co., Ltd.
14f-2, #1, Lane 25
Zhuangjing Rd.
Banqiao,  TW 220
Applicant Contact JUNNATA CHANG
Correspondent
Shanghai Ruike Sports Goods Co., Ltd.
14f-2, #1, Lane 25
Zhuangjing Rd.
Banqiao,  TW 220
Correspondent Contact JUNNATA CHANG
Regulation Number890.3800
Classification Product Code
INI  
Date Received09/08/2006
Decision Date 12/14/2006
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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