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510(k) Data Aggregation

    K Number
    K251458

    Validate with FDA (Live)

    Date Cleared
    2026-01-15

    (248 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

    This 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

    The product is intended only carry one person and used as a means of transportation for people with disabilities or incomplete walking ability (excluding obesity).

    The electric wheelchair is classified as class A, which is suitable for use on flat walking paths indoors and near buildings.

    The maximum occupant mass is 100kg.

    The Electric Wheelchair is a battery powered four wheeled vehicle.

    It consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery power indicator, ON/OFF button, horn button, speed indicator, speed control button, joystick, lighting switch, USB interface), arm supports, two rear wheels, two casters(front wheels), Foot support, anti-tip devices.

    The wheelchair can easily fold and unfold for transportation or storage.

    The controller handle (joystick) is equipped on the control pad that attaches to the right arm rest. While there is a bluetooth music play function equipped on the left arm rest. The bluetooth function does not connect to the controller, so it will not affect the normal operation of the wheelchair at all.

    AI/ML Overview

    N/A

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