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510(k) Data Aggregation

    K Number
    K252590

    Validate with FDA (Live)

    Device Name
    Powered Mobility Scooter (PMS105, GUT177, GCAT047)
    Manufacturer
    Intradin (Shanghai) Machinery Co., Ltd.
    Date Cleared
    2025-11-21

    (98 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K250027
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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, Model PMS105, GUT177, GCAT047 is mainly composed of frame, two front wheel, two drive wheel, control system, motor and drive device, armrest, backrest, seat cushion, pedal, battery and charger. The traveling speed is controlled by the motor, and the traveling direction is manually controlled by the accompanying personnel or passengers. 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. When encountering an obstacle in front, please make a detour to avoid the danger of overturning the scooter. It has a driving range of 9.2 km between charges. It is capable of carrying a driver weighing up to 150kg.

    AI/ML Overview

    N/A

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