PACE SAVER LITTLE JR

Vehicle, Motorized 3-wheeled

BURKE MOBILITY PRODUCTS

The following data is part of a premarket notification filed by Burke Mobility Products with the FDA for Pace Saver Little Jr.

Pre-market Notification Details

Device IDK925122
510k NumberK925122
Device Name:PACE SAVER LITTLE JR
ClassificationVehicle, Motorized 3-wheeled
Applicant BURKE MOBILITY PRODUCTS P.O. BOX 1064 Mission,  KS  66222
ContactDuwayne E Kramer
CorrespondentDuwayne E Kramer
BURKE MOBILITY PRODUCTS P.O. BOX 1064 Mission,  KS  66222
Product CodeINI  
CFR Regulation Number890.3800 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-09
Decision Date1994-03-30

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