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510(k) Data Aggregation

    K Number
    K142099
    Device Name
    CUTANEOUS ELECTRODES
    Manufacturer
    BIO PROTECH, INC.
    Date Cleared
    2014-11-17

    (108 days)

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

    CUTANEOUS ELECTRODES

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

    PROTENS reusable, self-adhering, over-the-counter Cutaneous electrodes are indicated for use with electrical stimulation device. Some common types of electrical stimulation device include, but are not limited to, transcutaneous nerve stimulation (TENS), electrical muscle stimulation (EMS) device, Neuromuscular Electrical Stimulation (NMES/FES) device and Microcurrent electrical nerve stimulation (MENS), Interferential stimulation (IF). Cutaneous electrodes are passive devices serving as an interface between a user's skin and an electrical stimulation device.

    Device Description

    Cutaneous electrodes are passive devices serving as an interface between a user's skin and an electrical stimulation device.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for Bio Protech Inc.'s PROTENS Reusable Stimulating Electrodes. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the letter does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.

    Therefore, I cannot provide a response to your request as the document does not contain the necessary information.

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