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Cervella

FDA 510(k)

Class II (US FDA 510(k))

510(k) K182311

by Innovative Neurological Devices, LLC

Identifiers

510(k) Number
K182311 FDA 510(k)
FDA Product Code
QJQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5800 FDA 510(k)
Regulation Number
882.5800 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Cervella is a Cranial Electrotherapy Stimulator used to treat insomnia and/or anxiety. This device delivers electrical stimulation to the brain to help manage these conditions. It is classified as a Class II medical device in the neurology specialty.

The Cervella device is supplied by Innovative Neurological Devices, LLC and received FDA 510(k) clearance on March 7, 2019. It is not specified as single-use or reusable, and no MRI safety information is provided. The device is stored according to manufacturer instructions and is authorized for use in the United States.

Frequently asked questions

What is the Cervella device used for?

Cervella is a Cranial Electrotherapy Stimulator designed to treat insomnia and/or anxiety by delivering electrical stimulation to the brain to help manage these conditions.

Is the Cervella device single-use or reusable?

The device description does not specify whether Cervella is single-use or reusable. Users should refer to the manufacturer's instructions for proper usage and disposal guidelines.

What regulatory approvals does the Cervella device have?

Cervella received FDA 510(k) clearance on March 7, 2019, and is classified as a Class II medical device in the neurology specialty. It is authorized for use in the United States.

How is the Cervella device supplied and stored?

The Cervella device is supplied by Innovative Neurological Devices, LLC and should be stored according to the manufacturer's instructions. No specific storage conditions are provided in the device data.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Innovative Neurological Devices, LLC

Sources (1)

  • FDA 510(k) K182311 24 fields · synced Sep 23, 2026