FDA applicant
Neurovalens Limited
FDA records 3 decisions for Neurovalens Limited (Portglenone, GB) from 2023 to 2026: 2 510(k) clearances and 1 De Novo grant. Most are in product codes QJQ (Cranial Electrotherapy Stimulator To Treat…) and SHX (Transcranial Nerve Stimulation Device For The…). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Neurovalens , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Neurovalens Limited’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Neurovalens Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report