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510(k) Data Aggregation

    K Number
    K984199
    Device Name
    EXONIX
    Manufacturer
    FIBRA SONICS, INC.
    Date Cleared
    1999-02-17

    (85 days)

    Product Code
    IMI
    Regulation Number
    890.5300
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EXONIX

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

    The Fibra Sonics Exonix Ultrasound device is used to produce therapeutic deep heat for the following conditions:

    • Temporary relief of pain
    • Muscle Spasms
    • Joint contractures
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but to provide an answer to this prompt, I would need additional information regarding the performance data of the Exonix device. The provided text is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a predicate device and can be marketed. However, it does not contain the specific acceptance criteria, reported device performance, details of the study that proves the device meets the acceptance criteria, or any of the other requested information (e.g., sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details).

    To answer your request, I would need access to the actual 510(k) summary or the underlying study report submitted to the FDA for the Exonix device.

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