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510(k) Data Aggregation

    K Number
    K244003
    Device Name
    Electrically powered wheelchair
    Date Cleared
    2025-03-26

    (90 days)

    Product Code
    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 AuthorizedThirdparty
    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
    This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design.The entire wheelchair can be disassembled, making it easy to carry. The wheelchair comes equipped with an electronically controlled rising seat that allows the user 280mm/11" of seat height adjustment using the joystick. The armrest can be flipped upside down, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device. The wheelchair uses lead-acid Battery as its power source. The controls the drive leftright motor to realize the wheelchair forward, backward and turn functions. The frame of the device is carbon steel. The front wheels suitable for rotation, acceleration, retrograde and other actions of the wheels movement will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires. When in use, the operator drives the motor of the rear wheel by operating the controller joystick to achieve the rear wheels movement. The DC brushless motor and brake system are fixed on the rear wheels. The max loading of the device is 136KG. Only for one person sit.
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    K Number
    K243961
    Device Name
    Electrically Powered Wheelchair
    Date Cleared
    2025-02-12

    (51 days)

    Product Code
    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 AuthorizedThirdparty
    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
    This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded and it can be easily carried or rolled after folding. The seat cushion is detachable. The armrest can be flipped upside down, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device. The wheelchair uses lithium batteries as its power source. The controls the drive leftright motor to realize the wheelchair forward, backward and turn functions. The frame of the device is aluminum alloy. The front wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires. When in use, the operator drives the motor of the rear wheel by operating the controller joystick to achieve the rear wheels movement. The DC brushless motor and brake system are fixed on the rear wheels. The max loading of the device is 120KG. Only for one person sit.
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    K Number
    K243962
    Device Name
    Electrically Powered Wheelchair
    Date Cleared
    2025-02-12

    (51 days)

    Product Code
    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 AuthorizedThirdparty
    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
    This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded and it can be easily carried or rolled after folding. The seat cushion is detachable. The armrest can be flipped upside down, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device. The wheelchair uses lithium batteries as its power source. The controls the drive left/right motor to realize the wheelchair forward, backward and turn functions. The frame of the device is Magnesium alloy. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires.When in use, the operator drives the motor of the rear wheel by operating the controller joystick to achieve the rear wheels movement. The DC brushless motor and brake system are fixed on the rear wheels. The max loading of the device is 120KG. Only for one person sit.
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    K Number
    K241337
    Device Name
    Electrically powered wheelchair (HP202)
    Date Cleared
    2024-10-17

    (157 days)

    Product Code
    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 AuthorizedThirdparty
    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 Electrically powered wheelchair is a motor driven, indoor 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. It is mainly composed of front wheel, drive wheel, frame, controller (joystick), motor and drive devices, armrest, backrest, seat belt, footrest, battery box and charger. The device is powered by Li-ion Battery pack (25V 10Ah) 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 user can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. When the user releases the joystick will automatically go 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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    K Number
    K241632
    Device Name
    Electrically powered wheelchair
    Date Cleared
    2024-10-16

    (132 days)

    Product Code
    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 AuthorizedThirdparty
    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
    This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded by one button and it can be easily carried or rolled after folding, The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the wheelchair by the wheelchair by themselves through the control device. The wheelchair uses lithium batteries as its power source. The drive left/right motor to realize the wheelchair forward, backward and turn functions. The frame of the device is carbon fiber. The front wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels mover will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires. When in use, the operator drives the motor of the rear wheel by operating the controller handle (joystick) to achieve the rear wheels movement. The DC Brushless motor and Brake system are fixed on the rear wheels. The max loading of the device is 125KG. Only for one person sit.
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    K Number
    K212503
    Device Name
    HP458E Electrically Powered Wheelchair
    Date Cleared
    2022-01-18

    (162 days)

    Product Code
    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 AuthorizedThirdparty
    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
    Date Cleared
    2022-01-04

    (221 days)

    Product Code
    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 AuthorizedThirdparty
    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
    Date Cleared
    2021-09-28

    (449 days)

    Product Code
    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 AuthorizedThirdparty
    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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