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510(k) Data Aggregation

    K Number
    K253307

    Validate with FDA (Live)

    Date Cleared
    2026-03-27

    (179 days)

    Product Code
    Regulation Number
    890.3860
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Electric wheelchair 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 Electric wheelchair is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people.

    The Electric wheelchair is composed of frame, motor, controller, lithium battery and seat cushion. The Electric wheelchair is powered by lithium battery which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet when the device is not in use.

    The patient can activate the controller handle (joystick) to control the speed and direction of the Electric wheelchair movement. In addition, when the patient releases the joystick, it will return back to the central position and the Electric wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the Electric wheelchair will be re-energized.

    AI/ML Overview

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