OBP — Transcranial Magnetic Stimulator Class II
FDA product code OBP covers "Transcranial Magnetic Stimulator", a Class II medical device regulated under 21 CFR 882.5805. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260396 | fidelity biopharma | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaSt | September 6, 2026 |
| K260691 | btl industries | BTL-699 | August 23, 2026 |
| K261228 | brain ultimate | QuickVision Ultimate rTMS | August 14, 2026 |
| K260560 | mag and more | Apollo TMS Therapy System;Apollo light TMS Therapy System | May 22, 2026 |
| K260189 | tonica elektronik | MagVenture Accelerated TMS (aTMS) Therapy System | May 22, 2026 |
| K252358 | nexstim | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | March 20, 2026 |
| K253098 | nexstim | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | March 20, 2026 |
| 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 |