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510(k) Data Aggregation

    K Number
    K990370
    Device Name
    MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES)
    Manufacturer
    MSB,UK
    Date Cleared
    1999-04-12

    (63 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Stimus latio OV INTERFERENTIAL

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for MSB (Electrical Stimulation) Electrodes from 1999. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

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

    The document primarily focuses on regulatory approval based on substantial equivalence, not on the detailed technical data or clinical study results that would typically include acceptance criteria and performance metrics.

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