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Wavi Headset and Wavi eSoc Single Use Electrode Contacts

FDA 510(k)

Class II (US FDA 510(k))

510(k) K162460

by Wavi Co.

Identifiers

510(k) Number
K162460 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)

The Wavi Headset and Wavi eSoc Single Use Electrode Contacts are a medical device used for routine clinical and research settings where rapid placement of a number of EEG electrodes is desired. It is classified as an Electrode, Cutaneous, and is used in the field of Neurology.

The device is supplied as a single-use product and has been cleared by the FDA with a 510K number of K162460. It is classified as a class 2 device and has a product code of GXY. The device is intended for use in settings where rapid placement of EEG electrodes is desired, and it is stored and used in accordance with the manufacturer's instructions.

Frequently asked questions

What is the WAVi Headset used for?

The WAVi Headset is used for routine clinical and research settings where rapid placement of a number of EEG electrodes is desired, particularly in the field of Neurology.

Is the WAVi Headset a single-use product?

Yes, the WAVi Headset and eSoc Single Use Electrode Contacts are supplied as a single-use product, intended to be used once and then discarded.

How is the WAVi Headset stored and used?

The WAVi Headset is stored and used in accordance with the manufacturer's instructions, ensuring proper handling and application in clinical and research settings.

What is the regulatory status of the WAVi Headset?

The WAVi Headset has been cleared by the FDA with a 510K number of K162460, indicating it has been found to be substantially equivalent to a predicate device.

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: WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts (K162460 ..., WAVi™ Headset And WAVi™ ESoc™ Single Use Electrode Contacts 510 (k ..., WAVi Headset and WAVi eSoc Single Use Electrode Contacts, Wavi Co. FDA 510 (k) Products 2022

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wavi Co.

Sources (1)

  • FDA 510(k) K162460 24 fields · synced Oct 1, 2026