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510(k) Data Aggregation

    K Number
    K980229
    Device Name
    MSB TENS ELECTRODES (DISPOSABLE)
    Manufacturer
    MSB LTD.
    Date Cleared
    1998-02-27

    (36 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MSB TENS ELECTRODES (DISPOSABLE)

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

    TENS Electrodes are to be used for nerve stimulation.

    Device Description

    TENS Electrodes

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for MSB Tens Electrodes and the FDA's determination of substantial equivalence. However, it does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.

    The document is a regulatory letter from the FDA to MSB Limited, confirming that their Tens Electrodes are substantially equivalent to devices marketed prior to May 28, 1976. This letter signifies a regulatory clearance to market the device, but it does not detail the testing or studies that led to this determination. Such studies would typically be part of the 510(k) submission, but their results are not included in this particular document.

    Therefore, I cannot provide the requested information based on the given text.

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