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510(k) Data Aggregation

    K Number
    K972038
    Device Name
    INTRUDER
    Manufacturer
    THE BUZZZ CORP.
    Date Cleared
    1997-07-03

    (31 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    K972037
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To offer to the consuming public, an electric 4-wheel scooter, that is reliable, safe and affordable.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in the prompt. The text is a letter from the FDA to American Dream International Corporation regarding the 510(k) clearance of their "Stealth," "Prowler," and "Intruder" devices, which are described as a 4-wheel electric scooter.

    The letter discusses regulatory classifications and general controls, but it does not include any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot generate the table or answer the specific questions about the device's performance study.

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