510(k) K243460
K243460 is an FDA 510(k) premarket notification submitted by Brain Ultimate, Inc. for the device "Ultimate rTMS". The FDA issued a decision of Substantially Equivalent on April 17, 2025. The device falls under product code OBP (Transcranial Magnetic Stimulator), a Class II device regulated under 21 CFR 882.5805. 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 Stimulator
- Device Class
- Class II
- Regulation Number
- 882.5805
- Review Panel
- NE
- Submission Type
A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.