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510(k) Data Aggregation

    K Number
    K030564
    Device Name
    THERMOSKIN CONDUCTIVE PADS
    Manufacturer
    UNITED PACIFIC, INC.
    Date Cleared
    2003-09-12

    (203 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

    Electrodes intend for use as re-usable (by single patient), cutaneous, flexible conductive garment / fabric electrodes for interface between electrical stimulators, such as powered muscle stimulators, interferential devices, galvanic devices, trans-cutaneous electrical nerve stimulators etc., and a patient's skin for the delivery of clectrical stimulation.

    Device Description

    Thermoskin Conductive Pads are re-usable (by single patient), cutaneous, flexible conductive garment / fabric electrodes.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested. The document is a 510(k) clearance letter from the FDA for a device called "Thermoskin Conductive Pads." It states that the device is substantially equivalent to legally marketed predicate devices and lists its indications for use.

    However, the letter does not include any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. This type of information is typically found in the 510(k) submission itself or in a separate study report, none of which are present in the provided text.

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