# DEN250013: Modius Spero

- Pathway: De Novo (Direct)
- Applicant: Neurovalens Limited
- Decided: May 8, 2026 after 387 days
- Product code: SHX (Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms)
- Device class: 2
- Regulation: 21 CFR 882.5807
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
Modius Spero is a home-use device indicated for the treatment of symptoms associated with post-traumatic stress disorder (PTSD) for use in conjunction with a comprehensive treatment plan under the direction of a healthcare professional, in adults aged 22 and older.

Source page: https://510kreport.com/device/DEN250013
Methodology: https://510kreport.com/methodology