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510(k) Data Aggregation

    K Number
    K253599

    Validate with FDA (Live)

    Date Cleared
    2026-02-17

    (91 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

    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 Electric Wheelchair is a battery powered four wheeled vehicle.

    The model W-A807 consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery indicator light, ON/OFF, speed indicator light, decrease speed, horn, joystick, charging port), arm supports, two rear wheels(drive wheel), two casters, foot support, anti-tip devices, handle.

    The model W-A807L consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery indicator light, ON/OFF, speed indicator light, decrease speed, increase speed, horn, lean back, backrest recline, joystick, charging port), arm supports, two rear wheels(drive wheel), two casters, foot support, anti-tip devices, handle, linear actuator.

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

    The wheelchair uses lithium battery as its power source. The controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions.

    The frame of the device is Aluminum. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are driving wheels to control the speed and direction. The wheels are solid PU tires.

    When in use, the operator drives the motor of the rear wheel by operating the controller to achieve the rear wheels movement.

    The DC Brushed Motor and brake system are fixed on the rear wheels.

    The max loading of the device is 136 kg. Only for one person sit.

    AI/ML Overview

    N/A

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