510(k) DEN240076
DEN240076 is an FDA 510(k) premarket notification submitted by Neurovalens Limited for the device "Modius Lean". The FDA issued a decision of De Novo Granted on October 17, 2025. The device falls under product code SFW (Cranial Electrotherapy Stimulator For Weight Management), a Class I device regulated under 21 CFR 876.5984. Neurovalens Limited has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 17, 2025
- Date Received
- December 18, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cranial Electrotherapy Stimulator For Weight Management
- Device Class
- Class I
- Regulation Number
- 876.5984
- Review Panel
- GU
- Submission Type
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.