FDA 510(k)
FDA class 1
Unknown
🇬🇧 United Kingdom
Modius Lean
K Number: DEN240076
·
Decision Oct 17, 2025
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
3
Review Days
303
Basic Information
- Device Name
- Modius Lean
- K Number
- DEN240076
- Device Class
- FDA class 1
- Clearance Type
- Direct
- Regulation Number
- 876.5984
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Neurovalens Limited
- Date Received
- December 18, 2024
- Decision Date
- October 17, 2025
- Product Code
- SFW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SFW | Cranial Electrotherapy Stimulator For Weight Management | FDA class 1 | Gastroenterology, Urology |