SHX — Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms Class II
Classification Details
- Product Code
- SHX
- Device Class
- Class II
- Regulation Number
- 882.5807
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250013 | neurovalens limited | Modius Spero | May 8, 2026 |