Neurovalens Limited: FDA filings under this applicant name
FDA lists 2 510(k) clearances under 2 spellings of the applicant name “Neurovalens Limited” (first 2023, latest 2024), plus 2 De Novo decisions, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 230 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 217 |
| 2024 | 1 | 243 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Neurovalens Limited took a median 230 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 206 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QJQ | Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety | 2 | 2 |
| SFW | Cranial Electrotherapy Stimulator For Weight Management | 1 | 0 |
| SHX | Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms | 1 | 0 |
Review panels
Most recent Neurovalens Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232253 | Modius Stress | QJQ | 2024-03-27 | 243 |
| K230826 | Modius Sleep | QJQ | 2023-10-27 | 217 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN250013 | De Novo | Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms | 2026-05-08 |
| DEN240076 | De Novo | Cranial Electrotherapy Stimulator For Weight Management | 2025-10-17 |
Recalls
openFDA lists no recalls under a recalling firm named Neurovalens Limited.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Neurovalens Limited is the lead sponsor of 16 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06956118: Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Improving Sleep in Visually Impaired Patients (Recruiting, started 2025-12-01)
- NCT06956105: Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Anxiety in Adolescents (Recruiting, started 2025-09-08)
- NCT06051864: Electrical Vestibular Nerve Stimulation (VeNS) As a Treatment for Depression (Completed, started 2023-12-03)
- NCT05242367: Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for PTSD (Completed, started 2023-02-13)
- NCT05845658: Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Anxiety: A Randomized Clinical Trial (Completed, started 2022-10-25)
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Neurovalens Limited (3)
- Neurovalens , Ltd. (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under Neurovalens Limited?
FDA lists 2 510(k) clearances under 2 spellings of the applicant name “Neurovalens Limited” (first 2023, latest 2024), plus 2 De Novo decisions, across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Neurovalens Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neurovalens Limited is 230 days.
Which FDA product codes appear under Neurovalens Limited?
The most frequent FDA product codes under this applicant name are QJQ (Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety, 2); SFW (Cranial Electrotherapy Stimulator For Weight Management, 1); SHX (Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms, 1).
Next steps
- See all 2 Neurovalens Limited clearances with predicates and recalls
- Run predicate analysis for product code QJQ, Neurovalens Limited's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.