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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
NE
Reference & Predicate 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.

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).