SHX
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5807
- Medical specialty
- Neurology
- FDA definition
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Modius Spero (DEN250013) | Neurovalens Limited | 2026-05-08 |
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