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    K Number
    K070612
    Device Name
    TOP-RANK ADHESIVE ELECTRODE
    Manufacturer
    TOP-RANK HEALTH CARE EQUIPMENT CO., LTD.
    Date Cleared
    2007-05-07

    (63 days)

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

    TOP-RANK ADHESIVE ELECTRODE

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

    Top-Rank Adhesive Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed, Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Top-Rank Adhesive Electrode." This document is a regulatory approval letter and does not contain any information about acceptance criteria, study details, performance metrics, ground truth establishment, or sample sizes related to the device's technical performance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input document. The document primarily focuses on the device's classification, intended use, and regulatory compliance for marketing purposes in the US.

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