SFW
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cranial Electrotherapy Stimulator For Weight Management
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5984
- Medical specialty
- Gastroenterology, Urology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Modius Lean (DEN240076) | Neurovalens Limited | 2025-10-17 |
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