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EEG Electrode Template

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191225

by Rhythmlink International, LLC

Identifiers

510(k) Number
K191225 FDA 510(k)
FDA Product Code
GXY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1320 FDA 510(k)
Regulation Number
882.1320 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

An EEG Electrode Template is a device designed to assist in the fast and accurate placement of EEG electrodes. It is a disposable elastic template used to guide electrode positioning during electroencephalography procedures.

The device is supplied as a disposable, non-sterile, single-use product intended for use in clinical settings. It is not MRI conditional or CT compatible based on the provided data, and no specific sizes, storage conditions, or additional authorizations beyond FDA 510(k) clearance (K191225) are specified in the data.

Frequently asked questions

What is the EEG Electrode Template used for?

The EEG Electrode Template is designed to assist in the fast and accurate placement of EEG electrodes during electroencephalography procedures by guiding electrode positioning on the scalp.

Is the EEG Electrode Template sterile or non-sterile, and is it reusable?

The EEG Electrode Template is supplied as a disposable, non-sterile, single-use product, meaning it is intended for one-time use only and should not be reprocessed or reused due to infection control and material integrity concerns.

How is the EEG Electrode Template supplied and what are its storage requirements?

The device is supplied as a disposable elastic template; however, specific storage conditions are not detailed in the provided data, so users should follow standard clinical practices for non-sterile disposable medical devices unless otherwise labeled.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Rhythmlink Template - Rhythmlink, Featured Products - Rhythmlink, EEG Electrode Template (K191225) - FDA 510 (k), PDF K191225 - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Rhythmlink International, LLC

Sources (1)

  • FDA 510(k) K191225 24 fields · synced Sep 28, 2026