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510(k) Data Aggregation

    K Number
    K020119
    Date Cleared
    2002-07-22

    (189 days)

    Product Code
    Regulation Number
    890.5860
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VECTORSONIC, MODEL VU-200

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

    The indications for use for the interferential therapy are:

    1. Relaxation of muscle spasm;
    2. Prevention or retardation of disuse atrophy;
    3. Increasing local blood flow;
    4. Muscle re-education;
    5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
    6. Maintaining or increasing range of motion.

    The indications for use for the ultrasound therapy are:

    1. Relief or reduction of pain;
    2. Reduction of muscle spasm;
    3. Joint contracture; and
    4. Local increase in circulation.

    The indication for use for the combined therapy is:

    1. Reduction of muscle spasm.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, any specific study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. The document is an FDA 510(k) clearance letter for the Vectorsonic Model VU-200, which outlines its indications for use and regulatory classification, but does not contain the detailed study information you've requested.

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