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510(k) Data Aggregation

    K Number
    K972055
    Device Name
    MSI MAGNA-STYM
    Manufacturer
    MICROVAS SYSTEMS, INC.
    Date Cleared
    1997-08-29

    (88 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The proposed device will have the following indications: prevention and retardation of muscle disuse atrophy, increase local blood flow, increase range of motion, prevent venous thrombosis with immediate postsurgical stimulation of calf muscles; relaxation of muscle spasms.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding the MSI Magna-Stym device. It states that the device has been found substantially equivalent to a predicate device and can be marketed.

    However, the document does not contain any information about:

    • Acceptance criteria table or reported device performance metrics.
    • The study design, sample sizes, data provenance, number or qualifications of experts, or ground truth establishment for either test or training sets.
    • Whether a multi-reader, multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study was done.

    Therefore, I cannot provide the requested information based on the given text. The document is solely a regulatory letter of approval, not a technical study report.

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