DeviceClearance

Product code SFW— Gastroenterology, Urology

Modius Lean

Classification name
Cranial Electrotherapy Stimulator For Weight Management
Device class
Class 1
Regulation
21 CFR 876.5984
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SFW under 21 CFR 876.5984, via openFDA

Market context for product code SFW

FDA has cleared 1 device under product code SFW, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code SFW

Recent clearances under product code SFW

Data sourced from openFDA. This site is unofficial and independent of the FDA.