LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252862

    Validate with FDA (Live)

    Device Name
    Electric Wheelchair (DH01126)
    Manufacturer
    Foshan Dahao Medical Technology Co., Ltd.
    Date Cleared
    2025-12-08

    (90 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Age Range
    All
    Reference & Predicate Devices
    K241529
    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 subject Electric Wheelchair is a wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk designed to be propelled by power from electric motors. The electronic control of speed and direction can be performed by the occupant with the help of controlling joystick. The device can be quickly folded and disassembled, which makes it convenient to be stored or placed at the trunk of vehicles while traveling.

    The subject Electric Wheelchair are intended to provide mobility to a disabled or elderly limited to a seated position. It is of indoor and outdoor type, suitable for the use indoor and flat path near buildings, but not on grass, gravel roads, large slopes or motorway, neither on muddy, rugged, soft, narrow, icy road, bad roads such as dangerous roads without guardrails or waterways.

    The DH01126 Electric Wheelchair consists of two parts, the wheelchair main body and the electrical part. The main body includes a main foldable frame, two armrests, a backrest, a seat cushion, two rear driving wheels and two front wheels. The electrical part is composed of two 24V DC motors, two brakes, lithium battery, a controller and an off-board charger.

    The device is powered by Li-ion battery, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet when the device is not in use.

    The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair. The further the joystick is pushed from its central position, the faster the wheelchair moves, when it is released, it will automatically reset and brake.

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

    The max loading of both models is 100KG. Only for one person sit.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1