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510(k) Data Aggregation

    K Number
    K253849

    Validate with FDA (Live)

    Date Cleared
    2026-03-20

    (108 days)

    Product Code
    Regulation Number
    890.3860
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    Device Description
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    K Number
    K252101

    Validate with FDA (Live)

    Device Name
    JWG-1
    Date Cleared
    2026-03-19

    (259 days)

    Product Code
    Regulation Number
    890.3860
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
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    K Number
    K253870

    Validate with FDA (Live)

    Date Cleared
    2026-03-04

    (90 days)

    Product Code
    Regulation Number
    890.3860
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253789

    Validate with FDA (Live)

    Date Cleared
    2026-02-25

    (89 days)

    Product Code
    Regulation Number
    890.3860
    Age Range
    All
    Reference & Predicate Devices
    N/A
    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

    Not Found

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    K Number
    K253707

    Validate with FDA (Live)

    Date Cleared
    2026-02-24

    (92 days)

    Product Code
    Regulation Number
    890.3860
    Age Range
    All
    Reference & Predicate Devices
    N/A
    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

    Not Found

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    K Number
    K253599

    Validate with FDA (Live)

    Date Cleared
    2026-02-17

    (91 days)

    Product Code
    Regulation Number
    890.3860
    Age Range
    All
    Reference & Predicate Devices
    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 Electric Wheelchair is a battery powered four wheeled vehicle.

    The model W-A807 consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery indicator light, ON/OFF, speed indicator light, decrease speed, horn, joystick, charging port), arm supports, two rear wheels(drive wheel), two casters, foot support, anti-tip devices, handle.

    The model W-A807L consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery indicator light, ON/OFF, speed indicator light, decrease speed, increase speed, horn, lean back, backrest recline, joystick, charging port), arm supports, two rear wheels(drive wheel), two casters, foot support, anti-tip devices, handle, linear actuator.

    The wheelchair can easily fold and unfold for transportation or storage.

    The wheelchair uses lithium battery as its power source. The controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions.

    The frame of the device is Aluminum. 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. 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 to achieve the rear wheels movement.

    The DC Brushed Motor and brake system are fixed on the rear wheels.

    The max loading of the device is 136 kg. Only for one person sit.

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    K Number
    K251458

    Validate with FDA (Live)

    Date Cleared
    2026-01-15

    (248 days)

    Product Code
    Regulation Number
    890.3860
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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 people with disabilities or incomplete walking ability (excluding obesity).

    The electric wheelchair is classified as class A, which is suitable for use on flat walking paths indoors and near buildings.

    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, lighting switch, USB interface), 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.

    The controller handle (joystick) is equipped on the control pad that attaches to the right arm rest. While there is a bluetooth music play function equipped on the left arm rest. The bluetooth function does not connect to the controller, so it will not affect the normal operation of the wheelchair at all.

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    K Number
    K253276

    Validate with FDA (Live)

    Date Cleared
    2026-01-15

    (108 days)

    Product Code
    Regulation Number
    890.3860
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the Electric Wheelchair (Robooter E80), Model name: BBR-E80-01 and BBR-E80-02 is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

    Device Description

    The Electric Wheelchair (Robooter E80), Models name: BBR-E80-01,BBR-E80-02, is an indoor/outdoor, battery- operated, 2-wheel drive (rear-wheel drive) powered wheelchair.

    It consists of four modules: seat system, control system, braking system, and drive system. The user sits in the wheelchair seat and uses the control system.

    The control pad positioned on the right armrest, user can turn the wheelchair on, control the speed, and direct the movement.

    The braking system employs an electromagnetic brake, when release the controller rocker, the electromagnetic brakes will be actuated, and the electric wheelchair will stop in several seconds. Electromagnetic brake will not take effect immediately, it will take effect after the wheel rotates for 1/2 cycle.

    The wheelchair is powered by a 24V DC,12Ah or 20Ah rechargeable lithium-ion battery charged by an offboard lithium-ion battery charger. The wheelchair is driven by two DC motors.

    The Electric Wheelchair (Robooter E80), Models name: BBR-E80-01,BBR-E80-02, contains Bluetooth 4.1 BLE technology. The device can be controlled by the controller rocker or remote control by a smartphone app via Bluetooth 4.1 Low Energy (BLE) wireless communication interface. The smartphone app is used to drive the chair remotely. For safety, controller rocker control is priority over the remote control by design. The smartphone app can also view the battery's status, adjust the speed gear level and lock/unlock the unattended device.

    The wheelchair can be folded/expanded manually. The Left and right handrails (joystick) can be interchange.

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    K Number
    K251159

    Validate with FDA (Live)

    Device Name
    Power wheelchair
    Date Cleared
    2025-12-22

    (251 days)

    Product Code
    Regulation Number
    890.3860
    Age Range
    All
    Reference & Predicate Devices
    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

    This product consists of frame, wheels, seat, armrest, backrest, headrest, 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 backrest, headrest and armrest can be adjustable. Users can drive the wheelchair by themselves through the control device.

    The wheelchair uses lead-acid batteries as its power source. The controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions.

    The frame of the device is steel and aluminum. 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. 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 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 135KG. Only for one person sit.

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    K Number
    K252862

    Validate with FDA (Live)

    Date Cleared
    2025-12-08

    (90 days)

    Product Code
    Regulation Number
    890.3860
    Age Range
    All
    Reference & Predicate Devices
    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.

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