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510(k) Data Aggregation

    K Number
    K252829

    Validate with FDA (Live)

    Date Cleared
    2025-11-12

    (68 days)

    Product Code
    Regulation Number
    890.3860
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis 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 subject device consists of a frame, wheels, a seat, an armrest, a lithium battery, a motor, and a controller with a lightweight and compact design. The entire wheelchair can be folded, allowing it to be easily carried or rolled after folding. The seat cushion is detachable. The armrest can be flipped upside down, which is convenient for the elderly to move. Users can drive the wheelchair independently by controlling the device.

    It uses lithium batteries as its power source. The controller controls the drive left/right motor, enabling the wheelchair to move forward, backward, and turn.

    The frame of the device is made of Aluminum Alloy, the same as previously specified in PL001 of K113463. The front wheels are driven wheels that are suitable for rotation, acceleration, and retrograde motion, as well as other actions of the wheelchair. The front wheels' movement will be achieved by the thrust generated from the rear wheels. The rear wheels serve as the driving wheels, controlling speed and direction. The wheels are PU Solid tires. When in use, the operator drives the motor of the rear wheel by operating the controller's joystick to achieve movement of the rear wheel.

    The DC brushless motor and brake system are fixed on the rear wheels.

    The maximum loading capacity of the device is 136 kg. Only one person can sit.

    AI/ML Overview

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