AMIGO MODEL 590000

Vehicle, Motorized 3-wheeled

AMIGO MOBILITY INTL., INC.

The following data is part of a premarket notification filed by Amigo Mobility Intl., Inc. with the FDA for Amigo Model 590000.

Pre-market Notification Details

Device IDK983987
510k NumberK983987
Device Name:AMIGO MODEL 590000
ClassificationVehicle, Motorized 3-wheeled
Applicant AMIGO MOBILITY INTL., INC. 6693 DIXIE HWY. Bridgeport,  MI  48722
ContactDale Confer
CorrespondentDale Confer
AMIGO MOBILITY INTL., INC. 6693 DIXIE HWY. Bridgeport,  MI  48722
Product CodeINI  
CFR Regulation Number890.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-09
Decision Date1999-06-08

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