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510(k) Data Aggregation

    K Number
    K251159

    Validate with FDA (Live)

    Device Name
    Power wheelchair
    Date Cleared
    2025-12-22

    (251 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

    This product consists of frame, wheels, seat, armrest, backrest, headrest, battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded and it can be easily carried or rolled after folding. The backrest, headrest and armrest can be adjustable. Users can drive the wheelchair by themselves through the control device.

    The wheelchair uses lead-acid batteries 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 steel and 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 joystick to achieve the rear wheels movement.

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

    The max loading of the device is 135KG. Only for one person sit.

    AI/ML Overview

    N/A

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