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510(k) Data Aggregation

    K Number
    K240339
    Device Name
    Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08)
    Date Cleared
    2024-07-22

    (168 days)

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

    Shanghai Bangbang Robotics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the Electric Wheelchair (Robooter E60), Models name: BBR-E60-01,BBR-E60-02, BBR-E60-03, BBR-E60-04,BBR-E60-05,BBR-E60-06,BBR-E60-07,BBR-E60-08, 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 E60), Models name: BBR-E60-01, BBR-E60-02, BBR-E60-03, BBR-E60-04, BBR-E60-05, BBR-E60-06, BBR-E60-07, BBR-E60-08, is an indoor/outdoor, batteryoperated, 2-wheel drive (rear-wheel drive) powered wheelchair. It consists of four modules: seat system, control 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,20Ah or 25Ah rechargeable lithium-ion battery charged by an offboard lithium-ion battery charger. The wheelchair is driven by two DC motors. The Electric Wheelchair (Robooter E60), Models name: BBR-E60-01, BBR-E60-02, BBR-E60-03, BBR-E60-04, BBR-E60-05, BBR-E60-06, BBR-E60-07, BBR-E60-08, 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 controlled an optional Bluetooth remote controller (BBR-BLERC series) The wheelchair can be folded/expanded manually. The Left and right handrails (joystick) can be interchange.
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    K Number
    K231868
    Device Name
    Electric Wheelchair (Robooter E40), Model name: BBR-E40-01
    Date Cleared
    2023-10-31

    (127 days)

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

    Shanghai BangBang Robotics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 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 E40), Model name: BBR-E40-01 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 panel positioned on the right or left armrest allows the user to turn the wheelchair on, control the speed, and direct the movement. The braking system employs an electromagnetic brake. When the controller rocker is released, the electromagnetic brakes will be actuated, and the electric wheelchair will stop in several seconds. The 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, 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 E40), Model name: BBR-E40-01 contains Bluetooth 4.1 BLE technology. The device can be 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, 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
    K223393
    Device Name
    Electric Wheelchair
    Date Cleared
    2023-03-16

    (128 days)

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

    Shanghai BangBang Robotics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the Electric Wheelchair (Model: BBR-LY-01-01) 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 (Model: BBR-LY-01-01) is an indoor/outdoor, battery-operated, 2-wheel drive (rear-wheel drive) powered wheelchair. lt 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,20Ah rechargeable lithium-ion battery charged by an offboard lithium-ion battery charger. The wheelchair is driven by two DC motors. The Electric Wheelchair (Model: BBR-LY-01-01) 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 automatically.
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