SIG
- Product code
- SIG
- Device name
- Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5802
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
FDA classification 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).
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260402 | 2026-06-03 | Wave Neuroscience | MeRT System |
Official FDA classification page: SIG
Classification and pathway per current FDA publications. Data from openFDA (CC0).