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510(k) Data Aggregation

    K Number
    K020445
    Device Name
    THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG
    Manufacturer
    THE ELECTRODE STORE, INC.
    Date Cleared
    2002-05-10

    (88 days)

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

    THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG

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

    The Electrode Store™ Surface Cutaneous Electrode for EMG is indicated for non-invasive use as recording (active/reference) or stimulating electrode during electromyography (EMG), including nerve conduction studies (NCS) and evoked potential (EP) recordings.

    Device Description

    Not Found

    AI/ML Overview

    This looks like a 510(k) clearance letter for a medical device and not a study. The document confirms that "The Electrode Store™ Surface (Cutaneous) Electrode for EMG" is substantially equivalent to legally marketed predicate devices.

    Therefore, the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in this document. This letter is a regulatory compliance document, not a clinical study report. It does not contain data or design information regarding a clinical investigation to assess performance against specific acceptance criteria.

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