PRESTIGE-MOBIE

Vehicle, Motorized 3-wheeled

PRESTIGE SPORTING GOODS CO. LTD.

The following data is part of a premarket notification filed by Prestige Sporting Goods Co. Ltd. with the FDA for Prestige-mobie.

Pre-market Notification Details

Device IDK122749
510k NumberK122749
Device Name:PRESTIGE-MOBIE
ClassificationVehicle, Motorized 3-wheeled
Applicant PRESTIGE SPORTING GOODS CO. LTD. 16F-2(16A), NO. 462, SEC. 2 CHONGDE RD., BEITUN DIST. Taichung,  TW 406
ContactJunnata Chang
CorrespondentJunnata Chang
PRESTIGE SPORTING GOODS CO. LTD. 16F-2(16A), NO. 462, SEC. 2 CHONGDE RD., BEITUN DIST. Taichung,  TW 406
Product CodeINI  
CFR Regulation Number890.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-07
Decision Date2012-12-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00822383570471 K122749 000

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