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510(k) Data Aggregation

    K Number
    K242471
    Device Name
    Power Wheelchair (W5538)
    Date Cleared
    2024-11-18

    (90 days)

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

    Zhejiang Innuovo Rehabilitation Devices Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Power 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 Power wheelchair, W5538, 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. The device consists of front wheel, drive wheel, frame, controller, motor and drive devices, armrest, push-handle, backrest, seat cushion, footrest, battery box and charger. The device is powered by a Li-ion Battery pack (24V 12Ah, 288Wh) with 15 Km (9.3 miles) 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. In addition, when the patient releases the joystick, the joystick will return 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
    K242387
    Device Name
    Mobility Scooter (N3473)
    Date Cleared
    2024-10-11

    (60 days)

    Product Code
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhejiang Innuovo Rehabilitation Devices Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The mobility scooter 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 mobility scooter 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. The Mobility Scooter, Model N3473, has a base with magnesium alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, 1 rechargeable Lithium Battery with an off-board charger, a remote control switch. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.
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    K Number
    K240012
    Device Name
    Mobility Scooter (W3431)
    Date Cleared
    2024-05-02

    (121 days)

    Product Code
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhejiang Innuovo Rehabilitation Devices 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 Mobility Scooter, Model: W3431, has a base with Steal frame, two front wheels, a seat, a tiller console, electromagnetic brake, 2 rechargeable Lead-acid Batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.
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    K Number
    K230964
    Device Name
    Power Wheelchair (N5909)
    Date Cleared
    2023-12-13

    (252 days)

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

    Zhejiang Innuovo Rehabilitation Devices Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Power Wheelchair (N5909) is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
    Device Description
    This Power wheelchair, N5909, 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. The device consists of front wheel, drive wheel, frame, controller, motor, armrest, push-handle, backrest, seat cushion, footrest, battery box and charger.
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    K Number
    K231508
    Device Name
    Power Wheelchair, W5521
    Date Cleared
    2023-11-09

    (168 days)

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

    Zhejiang Innuovo Rehabilitation Devices Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Power Wheelchair, W5521, is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
    Device Description
    This Power wheelchair, W5521, 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. The device consists of front wheel, drive wheel, frame, controller, motor and drive devices, armrest, push-handle, backrest, seat cushion, footrest, battery box and charger. The device is powered by a Li-ion Battery pack (24V 10Ah, 240Wh) with 10 Km (6.2 miles) 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. In addition, when the patient releases the joystick will return 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
    K221026
    Device Name
    Power Wheelchair
    Date Cleared
    2022-07-01

    (86 days)

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

    Zhejiang Innuovo Rehabilitation Devices Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The W5905 Power 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. This product is suitabled people with mobility difficulties and elderly people.
    Device Description
    The subject Power 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 Power Wheelchair is 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 subject Power Wheelchair consists of two parts, the wheelchair main body and the electrical part. The main body includes a main foldable frame, two armrests, a seat cushion, a safety belt, two rear driving wheels and two front wheels. The electrical part is composed of two motors, two brakes, a li-ion battery, a controller and an off-board charger. The device is powered by a Li-ion battery (24V 12Ah) with 15 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 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.
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    K Number
    K220740
    Device Name
    Power Wheelchair, W5907 (Q50 R Carbon)
    Date Cleared
    2022-05-12

    (59 days)

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

    Zhejiang Innuovo Rehabilitation Devices Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Power 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 Power 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 device consists of front wheel, drive wheel, frame, controller, motor, armrest, push-handle, backrest, seat cushion, pedal, battery box and charger. The device is powered by 2 Li-ion Battery pack (24V 10Ah, 240Wh) with 20 Km (12.5 miles) 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 patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return 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
    K220747
    Device Name
    Power Wheelchair (N5515B)
    Date Cleared
    2022-05-12

    (59 days)

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

    Zhejiang Innuovo Rehabilitation Devices Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Power Wheelchair (N5515B) 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 Power 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 device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, pedal, battery box and charger. The device is powered by Li-ion Battery pack (24V 12Ah) with 15 Km (9.32 miles) 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 patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return 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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