Data / Medical devices / United Kingdom / Neurovalens
Neurovalens: FDA-registered device maker in Belfast, United Kingdom, 4 510(k) clearances
Neurovalens is registered with the FDA (registration 3027997270) in Belfast, United Kingdom. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 8, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027997270
- Address
- 7 James St South The Warehouse Floor 4, Belfast, United Kingdom, BT2 8DN
- Owner or operator
- Neurovalens (10089371)
- Roles
- Foreign private label distributor, Specification developer
- First device listed
- December 1, 2023
- Registered through
- 2027
- Brand names listed
- Modius Calm, Modius Lean, Modius Skin Wipes, Modius Sleep, Modius Spero
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cranial Electrotherapy Stimulator For Weight Management | SFW | 1 | Specification developer | accessdata.fda.gov |
| Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety | QJQ | 2 | Specification developer | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Foreign private label distributor | accessdata.fda.gov |
| Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms | SHX | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 8, 2026 | DEN250013 | Modius Spero | SHX | Unknown | Neurovalens Limited | accessdata.fda.gov |
| October 17, 2025 | DEN240076 | Modius Lean | SFW | Unknown | Neurovalens Limited | accessdata.fda.gov |
| March 27, 2024 | K232253 | Modius Stress | QJQ | Substantially Equivalent | Neurovalens Limited | accessdata.fda.gov |
| October 27, 2023 | K230826 | Modius Sleep | QJQ | Substantially Equivalent | Neurovalens , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
- All makers of Pad, Alcohol, Device Disinfectant
Updated May 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.