510(k) K260402
K260402 is an FDA 510(k) premarket notification submitted by Wave Neuroscience for the device "MeRT System". The FDA issued a decision of Substantially Equivalent on Jun 3, 2026. The device falls under product code SIG (Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)), a Class II device regulated under 21 CFR 882.5802.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 3, 2026
- Date Received
- Feb 6, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)
- Device Class
- Class II
- Regulation Number
- 882.5802
- Review Panel
- NE
- Submission Type
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).