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510(k) Data Aggregation

    K Number
    K253631

    Validate with FDA (Live)

    Date Cleared
    2026-02-23

    (96 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

    This mobility scooter 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.

    The Mobility Scooter, has a base with two front wheels, two rear wheels, two support wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, 1 rechargeable battery with an off-board charger, a key switch. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The scooter can only be operated on the flat road.

    AI/ML Overview

    N/A

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