510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250013Unknown

Modius Spero

Neurovalens, Portglenone, GB / Direct, Unknown
FDA source (opens on fda.gov)

DEN250013 is the FDA 510(k) clearance record for Modius Spero, a class II device, cleared for Neurovalens Limited on under FDA product code SHX (Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms). FDA's definition for product code SHX reads: "A transcranial nerve stimulation device for the treatment of post-traumatic stress disorder (PTSD) associated symptoms is a prescription, home-use, externally worn device that applies electrical stimulation to a location on the patient’s...". FDA records list 4 510(k) clearances for Neurovalens Limited, from to . As of , FDA records show no recalls naming DEN250013.

Clearance record

Decision date
Received
(387 days to decision)
Product code
SHX Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms
Regulation
21 CFR 882.5807
Device class
Class II
Review panel
Neurology
Applicant
Neurovalens Limited 8 Carmagrim Rd., Portglenone, GB
Third party review
No

Clearances, product code SHX

Trailing 12 months
1 clearance under product code SHX in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SHX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260