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510(k) Data Aggregation

    K Number
    K212503
    Device Name
    HP458E Electrically Powered Wheelchair
    Manufacturer
    Kunshan Hi-Fortune Health Products Co., Ltd.
    Date Cleared
    2022-01-18

    (162 days)

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

    Kunshan Hi-Fortune Health Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device 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, Electrically Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The Electrically Powered Wheelchair consists of two foldable armrests, a backrest, a cushion, a foldable frame, two rear driving wheels with hub seat motor/electromagnetic brake assemblies, two pivoting casters, a Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The electric wheelchair is intended to provide mobility to a person with a disability or an older adult limited to a sitting position. Folding design: This foldable electric wheelchair has main frame, rear frame, backrest frame, seat frame, front wheel frame and battery frame. Release the locking device of the backrest frame and the rear frame, push the backrest frame downward, drive the seat frame to rotate toward the backrest frame with the rotating mechanism, the two armrest frames rotate towards the direction of the seat frame. At the same time two front wheel frames move to the direction of the seat frame. When the back cushion is in contact with the seat cushion, the folding is completed. Joystick: This controls the speed and direction of the wheelchair. Push the joystick in the direction you wish to go. The further you push it, the faster the speed. Releasing the joystick stops the wheelchair and automatically applies the brakes. Controller: The controller includes a power switch, a speed adjustment button, a horn button and a direction joystick. The operation interface controller receives the operation signal and transmits it to the main board of the controller body, and sends a control signal to the electric wheelchair to adjust and operate the electric wheelchair. Wheel and frame connection method: First, the left and right frames are connected to the motor respectively, and then the motor shaft is connected to the wheel. The motor rotates to drive the wheels to rotate to drive the wheelchair. Frame design: 1. The frame tube of this product is mostly is aluminum tube. 2. 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 subject device has 6 inch front wheel and 10 inch rear tire. The motor of electric wheelchair is DC24V 120W; the battery is 25.2V 10.4AH, Li-ion battery; the charger is 24V/2A. Max. loading can not be over than 120Kgs. The following surfaces are re commended NOT to operate on: Sand surface Wet or icy surface Road maintenance hole metal cover Do not use on stairs Do not use escalators. Use the elevator. Too steep incline over 6 degrees. Obstacle climbing ability: 1.97" Do not use outdoors
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    K Number
    K211647
    Device Name
    HP358EA Electrically Powered Wheelchair
    Manufacturer
    Kunshan Hi-Fortune Health Products Co., Ltd.
    Date Cleared
    2022-01-04

    (221 days)

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

    Kunshan Hi-Fortune Health Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    Not Found
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    K Number
    K201855
    Device Name
    Electrically Powered Wheelchair -Model HP358E
    Manufacturer
    Kunshan Hi-Fortune Health Products Co., Ltd.
    Date Cleared
    2021-09-28

    (449 days)

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

    Kunshan Hi-Fortune Health Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device 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 Electrically Powered Wheelchair - Model HP358E is powered by Li-ion battery, driven by DC motor. Users control direction and adjust speed by controller. The main frame of the wheelchair is made of aluminum alloy. It has a seat base with four-wheeled and two with a back cover on the frame. Wheels are connected to the stainless steel axle receivers via stainless steel axles. On the front end of the frame are assembled two caster housings. Caster forks are mounted to these housings via steel axles. There are two rear caster wheels in back and anti-tip wheels in front to prevent the power chair from tipping. On the front end of the frame, upon the caster, a foot platform is assembled for foot holding. Two non-adjustable armrests are mounted on the frame for user's arm holding. Two grips mounted on the top end of the frame with a brake, and another brake is designed under the seat base. The backrest can be adjusted by squeezing yellow catches on the back together. A storage compartment located between the seat and foot platform. The joystick can be mounted on the left or right side using the quick release mechanism. The subject device has two 2 inch Anti-tippers, two 8 inch front wheels and two 12 inch rear wheels. The motor is DC24V 250W; the battery is 25.2 V 10.4Ah Li-ion battery; the charger is DC 24V, 2A. Max. loading can not be over than 125Kg, the maximum distance of travel on the fully charged battery is 10km and its maximum speed is 6km/h. The braking time is about 2~3s, and the braking distance is ≤1.0m.
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