Skip to contentDe Novo DEN240076
- Device
- Modius Lean
- Contact
- jason mckeown
- De Novo number
- DEN240076
- Product code
- SFW
- Regulation
- 876.5984
- Classification name
- cranial electrotherapy stimulator for weight management
- Decision
- granted (DENG)
- Decision date
- 2025-10-17
- Date received
- 2024-12-18
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- SFW
- Device name
- Cranial Electrotherapy Stimulator For Weight Management
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation
- 876.5984
- Implant
- N
- Life sustain/support
- N