DEN240076 is an FDA 510(k) submission for the Modius Lean. This device is classified as a Cranial Electrotherapy Stimulator For Weight Management (Class I - General Controls, product code SFW).
Submitted by Neurovalens Limited (Portglenone, GB). The FDA issued a Not Cleared (DENG) decision on October 17, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5984. 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..
| 510(k) Number | DEN240076 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 18, 2024 |
| Decision Date | October 17, 2025 |
| Days to Decision | 303 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | SFW - Cranial Electrotherapy Stimulator For Weight Management |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5984 |
| 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. |