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510(k) Data Aggregation

    K Number
    K981121

    Validate with FDA (Live)

    Device Name
    AMIGO RT
    Manufacturer
    AMIGO MOBILITY INTL., INC.
    Date Cleared
    1998-06-30

    (95 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Physical Medicine
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended use is personal transportation for senior active and walking impaired individuals.

    Device Description

    Not Found

    AI/ML Overview

    The provided documents are a 510(k) clearance letter from the FDA for a device named "Amigo RT." This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed. However, the letters do not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications for the device.

    Therefore, I cannot provide the requested information based on the given input. The documents are purely administrative regarding regulatory clearance.

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