510(k) DEN240076

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

October 17, 2025

Date Received

December 18, 2024

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Cranial Electrotherapy Stimulator For Weight Management

Device Class

Class I

Regulation Number

876.5984

Review Panel

GU

Submission Type

A cranial electrotherapy stimulator for weight management is a battery-powered device that applies electrical current to a patient's head through electrodes placed on the skin to support weight management in conjunction with diet and exercise. Devices in this classification use a low level of electrical current that is not intended to induce a seizure.