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510(k) Data Aggregation

    K Number
    K253980

    Validate with FDA (Live)

    Device Name
    Electrically Powered Wheelchair (Model YC-01)
    Manufacturer
    Yurob Rehabilitation Medical Co., Ltd.
    Date Cleared
    2026-03-27

    (105 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Age Range
    All
    Reference & Predicate Devices
    K232193
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Electrically Powered 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 device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, pedal, battery box and charger.

    Electrically Powered Wheelchair is powered by Li-ion Battery pack (25.55V 10.4Ah*2) with 11.8 km range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use. The materials of frame is Carbon fiber.

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

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

    AI/ML Overview

    N/A

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