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510(k) Data Aggregation

    K Number
    K243970
    Device Name
    Portable Wheelchair
    Manufacturer
    Intradin (Shanghai) Machinery Co., Ltd
    Date Cleared
    2025-03-07

    (74 days)

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

    Intradin (Shanghai) Machinery 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
    Portable Wheelchair
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    K Number
    K250027
    Device Name
    Powered Mobility Scooter
    Manufacturer
    Intradin (Shanghai) Machinery Co., Ltd
    Date Cleared
    2025-02-21

    (46 days)

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

    Intradin (Shanghai) Machinery Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powered Mobility scooteris intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    Powered Mobility Scooter
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    K Number
    K232692
    Device Name
    Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)
    Manufacturer
    Intradin (Shanghai) Machinery Co., Ltd
    Date Cleared
    2024-09-05

    (366 days)

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

    Intradin (Shanghai) Machinery Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powered Mobility Scooter is intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    The Powered Mobility Scooter. Models: PMS101. GUT112, is a battery powered three wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. It consists lithium battery with an off-board battery charger, Handle-bar, Brake, Seat, Back support, Frame, One Front wheel and Two Rear wheels. The scooter controlled through a thumb throttle. The left brake handle is controlled mechanical brake which lock the drum brake in the right rear wheel. When actuated brake handle, it will stop scooter and cut power supply to the motor .It has a driving range of 15.6 km between charges. It is capable of carrying a driver weighing up to 125 kg. The Powered Mobility Scooter, Models: PMS103, GUT140, is a battery powered three wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. It consists lithium battery with an off-board battery charger, Handle-bar, Brake, Seat, Back support, Frame, Armrest, One Front wheel and Two Rear wheels. The scooter controlled through a thumb throttle. The left brake handle is controlled mechanical brake which lock the drum brake in the right rear wheel. When actuated brake handle, it will stop scooter and cut power supply to the motor. It has a driving range of 10.4 km between charges. It is capable of carrying a driver weighing up to 125 kg.
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