LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K984021
    Device Name
    MS300
    Manufacturer
    LSI INTL., INC.
    Date Cleared
    1999-01-28

    (77 days)

    Product Code
    IPF,NOV
    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

    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 document is a 510(k) clearance letter from the FDA for the MS300 and MS400 devices and does not contain information about acceptance criteria or a study proving that the devices meet them.

    The document states that the FDA has determined the devices are substantially equivalent to devices marketed prior to May 28, 1976. This means the manufacturer did not have to submit new clinical study data to demonstrate safety and effectiveness if they could show substantial equivalence to an existing predicate device.

    Therefore, I cannot provide the requested information about acceptance criteria and the study details as it is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1