SFW · Cranial Electrotherapy Stimulator For Weight Management
Gastroenterology, Urology · 21 CFR 876.5984 · Class 1
Overview
| Product Code | SFW |
|---|---|
| Device Name | Cranial Electrotherapy Stimulator For Weight Management |
| Regulation | 21 CFR 876.5984 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Identification
Modius Lean is a non-invasive, home-use neurostimulation medical device intended to support weight management alongside diet and exercise, in adults aged 22 years and older, who have a Body Mass Index of 27kg/m2 and greater. It is a battery-powered device that applies electrical current to a patient's head through electrodes placed on the skin.
Classification Rationale
FDA has determined that the device can be classified in Class I. FDA believes that class I (general) controls provide reasonable assurance of the safety and effectiveness of the device type.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN240076 | Modius Lean | Neurovalens Limited | Oct 17, 2025 | DENG |
Top Applicants
- Neurovalens Limited — 1 clearance
