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510(k) Data Aggregation

    K Number
    K993130
    Device Name
    ULTRA-GARMENT ELECTRODE
    Manufacturer
    NEWWAVE MEDICAL LLC.
    Date Cleared
    1999-12-17

    (88 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    k943009,K932299
    Why did this record match?
    Reference Devices :

    K943009, K932299

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

    The "Ultra Garment Electrode" is intended to be used as an electrically conducting garment to be prescribed for usage by a physician for use where an electrode is appropriate.
    ULTRA GARMENTS: ARE USED WITH LEGALY MARKETED TRANSCUTAINEIOUS ELECTRICAL NERVE STIMULATORS, (LE.N.S.), HIGH VOLT PULSED GAVINIC STIMULATORS, (H.V.P.G.), AND INTERFERENTIAL. (INF), UNITS.

    Device Description

    The Ultra Garment Electrode is a Stretchable Electrically Conductive glove, sock, or sleeve, Reusable.

    AI/ML Overview

    This document does not contain information about the acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is a 510(k) summary for a medical device called "Ultra Garment Electrode," which is a physical device (a stretchable, electrically conductive glove, sock, or sleeve) and not an AI or software-based medical device.

    Therefore, I cannot provide the requested information.

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