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510(k) Data Aggregation

    K Number
    K984113
    Device Name
    MS400
    Manufacturer
    LSI INTL., INC.
    Date Cleared
    1999-01-28

    (72 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MS400

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Relaxation of Muscle Spasm
    • Prevention of Retardation of disuse atrophy.
    • Increasing local blood circulation
    • Muscle Re-education.
    • Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
    • Maintaining or increasing range of motion.
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter from the FDA to LSI International for their devices MS300 and MS400. This document focuses on the regulatory aspects of device approval (substantial equivalence to predicate devices) and does not contain information about specific acceptance criteria, study methodologies, or performance data of the MS300 and MS400 devices.

    Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications as it is not present in the provided text.

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