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510(k) Data Aggregation

    K Number
    K252275

    Validate with FDA (Live)

    Date Cleared
    2026-01-29

    (191 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

    The electric 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.

    Device Description

    The electric 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, Model DDF100, consists with two front wheels, two rear wheels, two rear anti-tip wheels, one seat system with one back support and two arm supports, an adjustable steering column, a tiller console, an electric motor, an electromagnetic brake, one rechargeable Lithium-Ion battery and one off-board charger.

    The movement of the wheelchair is controlled by the speed lever and steering column. The device is installed with an electromagnetic brake that will engage automatically when the wheelchair is not in use and the brake can be manually adjusted to free wheel mode. The scooter only can be operated on the flat road.

    AI/ML Overview

    N/A

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