510(k) DEN250013
DEN250013 is an FDA 510(k) premarket notification submitted by Neurovalens Limited for the device "Modius Spero". The FDA issued a decision of De Novo Granted on May 8, 2026. The device falls under product code SHX (Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms), a Class II device regulated under 21 CFR 882.5807. Neurovalens Limited has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 8, 2026
- Date Received
- April 16, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms
- Device Class
- Class II
- Regulation Number
- 882.5807
- Review Panel
- NE
- Submission Type
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 patients head. The device is not intended as a stand-alone therapy or to alter usual care treatment.