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510(k) Data Aggregation

    K Number
    K983987
    Device Name
    AMIGO MODEL 590000
    Manufacturer
    AMIGO MOBILITY INTL., INC.
    Date Cleared
    1999-06-08

    (211 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMIGO MODEL 590000

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The subject device and the predicate device intended use, e is personal transportation for walking impaired individuals.

    Device Description

    AMIGO MODEL 590000 (Joystick)

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device (Amigo Model 590000, a joystick-controlled personal transportation device for walking-impaired individuals). It is not a study report or clinical trial document. Therefore, it does not contain information about acceptance criteria, device performance metrics, sample sizes, expert qualifications, ground truth establishment, or any details about a study proving the device meets acceptance criteria for an AI/ML product.

    The letter explicitly states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This means the clearance is based on a comparison to existing predicate devices, not on a new study demonstrating performance against specific acceptance criteria in the way you've outlined for an AI/ML product.

    Therefore, I cannot extract the requested information from the provided text.

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