510(k) K243459
K243459 is an FDA 510(k) premarket notification submitted by Brain Ultimate, Inc. for the device "Ultimate rTMS for OCD (M-series)". The FDA issued a decision of Substantially Equivalent on April 17, 2025. The device falls under product code QCI (Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder), a Class II device regulated under 21 CFR 882.5802. Brain Ultimate, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2025
- Date Received
- November 8, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
- 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 towards brain areas outside cerebral cortex (e.g., cerebellum).