SFW

Cranial Electrotherapy Stimulator For Weight Management

Product code

SFW

Device name

Cranial Electrotherapy Stimulator For Weight Management

Device class

Class 1

21 CFR

21 CFR 876.5984

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K) Exempt

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-10-17.