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510(k) Data Aggregation

    K Number
    K250475
    Device Name
    Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)
    Manufacturer
    NINGBO BAICHEN MEDICAL DEVICES CO., LTD
    Date Cleared
    2025-05-27

    (97 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    NINGBO BAICHEN MEDICAL DEVICES CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Electric 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 product is intended only carry one person and used as a means of transportation for the old and infirm who have difficulty in moving. The maximum occupant mass is 100kg. The Electric Wheelchair is a battery powered four wheeled vehicle. It consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery power indicator, ON/OFF button, horn button, speed indicator, speed control button, joystick, Battery charger socket), arm supports, two rear wheels, two casters(front wheels), Foot support, anti-tip devices. The wheelchair can easily fold and unfold for transportation or storage.
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    K Number
    K232121
    Device Name
    Power wheelchair (Model:BC-EA8000)
    Manufacturer
    Ningbo Baichen Medical Devices Co., Ltd.
    Date Cleared
    2023-09-15

    (60 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ningbo Baichen Medical Devices Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Power wheelchair BC-EA8000 is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
    Device Description
    This Power wheelchair is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people. The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, pedal, battery box and charger. The device is powered by Li-ion Battery pack (24V 6Ah) with 10 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 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 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.
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