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510(k) Data Aggregation

    K Number
    K220827
    Device Name
    Electric Wheelchair
    Date Cleared
    2022-07-05

    (105 days)

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

    Foshan Dahao Medical Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The electric wheelchair (Model: DH01108(2)) is a motor driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.
    Device Description
    The proposed device, Electric Wheelchair , mainly powered by rechargeable battery, motivated by motor, driven by user controlling joystick and adjusting speed. The electric wheelchair is composed of front frame, rear frame, backrest frame, armrest, front wheel, controller, battery pack, motor rear wheel, footplate, seat cushion, back cushion, handle. The electric wheelchair is intended to provide mobility to a person with a disability or an older adult limited to a sitting position.This wheelchair is suitable for the user who with weight less than 100kg. The device is folding design. This foldable electric wheelchair has front frame, backrest frame,armrest. The wheelchair can be easily folded, when folding the wheelchair, turn over the armrest successively. Controller : The controller includes a power key/speed adjustment key , a direction joystick and speed light ,battery capacity light. Joystick: It is used to control the electric wheelchair drive direction and speed. The joystick pushes away in the same direction as the wheelchair moves forward. The wheelchair also provided with max speed limit setting so that user can select the max speed level by the round key. Frame design: overall size: 90*59*99cm, net weight: 22kg The operation mode of the folding mechanism is to remove the locking device by someone else and manually push the backrest frame to complete the folding operation under non-riding state. The motor of electric wheelchair is DC24V 200W*2; Inner power is DC24, 10Ah; The charger of Lithium ion battery Input:AC 100-240V;50-60Hz;1.2-0.5A; output : DC 24V,2,0A.
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