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K Number
K953356
Device Name
EMG RECORDING RING ELECTRODE
Manufacturer
CHALGREN ENTERPRISES, INC.
Date Cleared
1996-01-22

(189 days)

Product Code
GXY
Regulation Number
882.1320
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

EMG Recording Ring Electrode

AI/ML Overview

The provided text is a letter from the FDA to Chalgren Enterprises, Inc. regarding a 510(k) notification for an EMG Recording Ring Electrode. It states that the device is substantially equivalent to legally marketed devices.

This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. Therefore, I am unable to provide the requested details based on the input.

§ 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).