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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
Original Applicant
PRESTIGE SPORTING GOODS CO. LTD.
16f-2(16a), no. 462, sec. 2
chongde rd., beitun dist.
taichung,  TW 406
Original 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
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