Product code SFW

Device name

Cranial Electrotherapy Stimulator For Weight Management

Medical specialty

Gastroenterology, Urology

Device class

1

Regulation number

876.5984

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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.

Source

FDA openFDA device classification dataset