Modius Spero— 510(k) DEN250013

Name: FDA 510(k) clearance DEN250013
Creator: U.S. Food and Drug Administration
Published: 2026-05-08

Unknown

Neurovalens Limited

FDA 510(k) clearance DEN250013 for Modius Spero, Unknown on 2026-05-08. Applicant: Neurovalens Limited. Device class: 2.

Summary

Modius Spero is from Neurovalens, filed under SHX, which the record names "Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms".

Class II, 21 CFR 882.5807. Neurology is both the classification panel and the review panel. The record lists the submission type as Direct.

Neurovalens filed from Portglenone, United Kingdom. The decision date came 387 calendar days after the received date (April 16, 2025 to May 8, 2026).

Clearance details

Applicant: Neurovalens Limited
Product code: Product code SHX
Device class: Class 2
Regulation: 21 CFR 882.5807
Advisory panel: Neurology
Date received: 2025-04-16
Decision date: 2026-05-08
Decision: Unknown
Clearance type: Direct
Location: Portglenone, GB

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.