SFW — Cranial Electrotherapy Stimulator For Weight Management Class I
FDA product code SFW covers "Cranial Electrotherapy Stimulator For Weight Management", a Class I medical device regulated under 21 CFR 876.5984. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SFW
- Device Class
- Class I
- Regulation Number
- 876.5984
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240076 | neurovalens limited | Modius Lean | October 17, 2025 |