OBP — Transcranial Magnetic Stimulator Class II
Classification Details
- Product Code
- OBP
- Device Class
- Class II
- Regulation Number
- 882.5805
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251653 | soterix medical | SPRY TMS Therapy System (0550) | February 20, 2026 |
| K251391 | brainsway | BrainsWay Deep TMS System | November 7, 2025 |
| K250689 | teleemg | CloudTMS Edge | September 14, 2025 |
| K251449 | brainsway | BrainsWay Deep TMS System | September 13, 2025 |
| K243700 | mag and more | Apollo TMS Therapy System | September 4, 2025 |
| K243539 | mag and more | Apollo TMS Therapy System | August 18, 2025 |
| K251125 | tonica elektronik | MagVenture TMS Therapy System | August 11, 2025 |
| K251119 | tonica elektronik | MagVenture TMS Therapy System | August 8, 2025 |
| K252032 | tonica elektronik | T65 (9016E061-) | July 30, 2025 |
| K251210 | neuromodulatory devices and applications | Ampa One System (AMPA-001) | June 27, 2025 |
| K243460 | brain ultimate | Ultimate rTMS | April 17, 2025 |
| K243869 | magstim company limited | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy | March 17, 2025 |
| K243319 | neuromodulatory devices and applications | Ampa One System (AMPA-001) | February 13, 2025 |
| K241518 | magstim company limited | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy | August 30, 2024 |
| K222196 | brainsway | Deep TMS System | May 31, 2024 |
| K232639 | mag and more | Apollo TMS Therapy System | May 24, 2024 |
| K231926 | neuronetics | NeuroStar Advanced Therapy System (All previously cleared models) | March 22, 2024 |
| K233631 | revital lab | ZapStim Controller Application (Z1023) | February 9, 2024 |
| K232688 | neuroqore | NQ TMS for MDD (NQv1-MU-01) | December 29, 2023 |
| K233621 | neuronetics | NeuroStar Advanced Therapy System (Version 3.8) | December 13, 2023 |