Search Filters

Search Results

Found 50 results

510(k) Data Aggregation

    K Number
    K253340

    Validate with FDA (Live)

    Date Cleared
    2026-04-03

    (185 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
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K253307

    Validate with FDA (Live)

    Date Cleared
    2026-03-27

    (179 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 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

    This Electric 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 Electric wheelchair is composed of frame, motor, controller, lithium battery and seat cushion. The Electric wheelchair is powered by lithium 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 Electric wheelchair movement. In addition, when the patient releases the joystick, it will return back to the central position and the Electric wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the Electric wheelchair will be re-energized.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K254012

    Validate with FDA (Live)

    Date Cleared
    2026-03-24

    (99 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 product is a wheelchair which provides transport for the elderly and mobility-impaired individuals.

    The maximum loading weight of the device is 100kg.

    The wheelchair is a battery powered four wheeled vehicle.

    It consists one Li-ion Battery with an off-board battery charger, frame, controllers, motors, seat, back support, control device (including: Power on/off, battery power indicator, horn button, speed indicator, speed up/down button, charging port), two rear wheels, two front wheels, foot support.

    The wheelchair can easily fold for transportation or storage.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K253849

    Validate with FDA (Live)

    Date Cleared
    2026-03-20

    (108 days)

    Product Code
    Regulation Number
    890.3860
    Age Range
    18 - 999
    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 device, Electric Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed. Products for adult use.

    The Electric Wheelchair is a battery powered four wheeled vehicle. It consists of Li-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick controller, Control panel (including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheel, Rear wheels.

    The operation of the Controller: Use the On/Off button to turn on or turn off the power, The main function of the Joystick is to control the speed and direction of the wheelchair, the Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the Joystick is moving from the center, the faster the wheelchair runs. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric/ manual model change lever underneath the seat will allow for the brakes to engage or disengage. When adjusted to the manual model, the assistant can easily push the wheelchair. The Electric Wheelchair has a structure for quick assembly and disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling.

    When the wheelchair needs to stop, release the joystick. After a set period of time, the controller disconnects the solenoid brake power supply, and the internal spring squeezes the suction plate and friction plate to lock the motor, so as to brake.

    The braking time is about 1s, and the braking distance is ≤1.0m.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K253870

    Validate with FDA (Live)

    Date Cleared
    2026-03-04

    (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 product is intended only carry one person and used as a means of transportation for the disabled, the sick and the infirm.

    The electric wheelchair is classified as class A and the maximum occupant mass is 120kg.

    The electric wheelchair is a battery powered four wheeled vehicle.

    It consists one Lithium battery with an off-board battery charger, frame, controller system, motors, seat, back cushion, armrest, two rear wheels, two casters(front wheels), foot plate, anti-tip devices.

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

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    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

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    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

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    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.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    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.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    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.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 5