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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 K122749
Device Name PRESTIGE-MOBIE
Applicant
Prestige Sporting Goods Co. , Ltd.
16f-2(16a), # 462, Sec. 2, Chongde Rd., Beitun Dist.
Taichung,  TW 406
Applicant Contact JUNNATA CHANG
Correspondent
Prestige Sporting Goods 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 Received09/07/2012
Decision Date 12/27/2012
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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