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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), NO. 462, SEC. 2
CHONGDE RD., BEITUN DIST.
TAICHUNG,  TW 406
Applicant Contact JUNNATA CHANG
Correspondent
PRESTIGE SPORTING GOODS CO. LTD.
16F-2(16A), NO. 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
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