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510(k) Data Aggregation

    K Number
    K253936

    Validate with FDA (Live)

    Date Cleared
    2026-03-12

    (93 days)

    Product Code
    Regulation Number
    890.3800
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

    Device Description

    The Mobility Scooter is a battery powered four wheeled vehicle that provides mobility to a disabled or elderly person limited to a seated position. It is primarily for indoor use and restricted outdoor use on pavements or paved footpaths. The maximum loading weight is 120kg. It consists of one Lithium-ion battery with an off-board battery charger, frame, controllers, motors, seat, back support, control device (including power switch & speed adjustment, horn switch, throttle & brake, handlebars, head lamp switch, real-time speed, power), two rear wheels, two front wheels, foot support (pedal), and anti-tip devices. The battery can be dismantled for transportation and users can easily assemble the parts without tools. Model MJMA01 is not equipped with armrests, while MJMA02 is equipped with armrests.

    AI/ML Overview

    N/A

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