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510(k) Data Aggregation

    K Number
    K240990
    Device Name
    Mobility Scooter
    Manufacturer
    Zhejiang Innuovo Rehabilitation Devices Co.,Ltd.
    Date Cleared
    2024-09-10

    (152 days)

    Product Code
    INI
    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 Authorized
    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
    K240008
    Device Name
    Mobility Scooter (W3331)
    Manufacturer
    Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
    Date Cleared
    2024-06-05

    (155 days)

    Product Code
    INI
    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 Authorized
    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. Models: W3331. has a base with Steal frame, one front wheel, two rear 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
    K231428
    Device Name
    Mobility Scooter (Models: W3431D)
    Manufacturer
    Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
    Date Cleared
    2023-07-14

    (58 days)

    Product Code
    INI
    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 Authorized
    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, Models: W3431D, has a base with Steal frame, two front wheel, two rear 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
    K222507
    Device Name
    Mobility Scooter (Models: W3431Q, W3431R)
    Manufacturer
    Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
    Date Cleared
    2023-02-28

    (194 days)

    Product Code
    INI
    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 Authorized
    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 Scooters, Models: W3431Q, W3431R, have a base with Steal frame, two front wheel, two rear wheels, a seat, a tiller console, electric motor, 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
    K222495
    Device Name
    Mobility Scooter, Model: W3331F
    Manufacturer
    Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
    Date Cleared
    2022-10-17

    (60 days)

    Product Code
    INI
    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 Authorized
    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, Models: W3331F, has a base with Steal frame, one front wheel, two rear 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
    K220206
    Device Name
    Mobility Scooter
    Manufacturer
    Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
    Date Cleared
    2022-03-24

    (58 days)

    Product Code
    INI
    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 Authorized
    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, Models: W3468A, has a base with Steal frame, two front wheels, two rear 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
    K220207
    Device Name
    Mobility Scooter, Model W3468
    Manufacturer
    Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
    Date Cleared
    2022-03-24

    (58 days)

    Product Code
    INI
    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 Authorized
    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, Models W3468, has a base with Steal frame, two front wheels, a seat, a tiller console, electromagnetic brake, front light, USB charging port (Transfer power only), 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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