510(k) DEN240076
- Device
- Modius Lean
- Applicant
- Neurovalens Limited
- 510(k) number
- DEN240076
- Product code
- SFW
- Decision
- Unknown (DENG)
- Decision date
- 2025-10-17
- Date received
- 2024-12-18
- Regulation
- 876.5984
- Classification name
- Cranial Electrotherapy Stimulator For Weight Management
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 1
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jason Mckeown
- Address
- 8 Carmagrim Rd. Portglenone GB BT44 8BP BT44 8BP
FDA Registration Numbers#
- 3027997270
Source Documents#
510(k) summary PDF not indicated by FDA