SIG — Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd) Class II
FDA product code SIG covers "Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)", a Class II medical device regulated under 21 CFR 882.5802. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SIG
- Device Class
- Class II
- Regulation Number
- 882.5802
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields in brain areas outside cerebral cortex (e.g., cerebellum).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260402 | wave neuroscience | MeRT System | June 3, 2026 |