Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5805](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5805) → OBP — Transcranial Magnetic Stimulator # OBP · Transcranial Magnetic Stimulator _Neurology · 21 CFR 882.5805 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP ## Overview - **Product Code:** OBP - **Device Name:** Transcranial Magnetic Stimulator - **Regulation:** [21 CFR 882.5805](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5805) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) ## Identification A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy. ## Classification Rationale Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document. ## Special Controls *Classification.* Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document. ## Recent Cleared Devices (20 of 64) Showing 20 most recent of 64 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253098](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K253098.md) | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | Mar 20, 2026 | SESE | | [K252358](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K252358.md) | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | Mar 20, 2026 | SESE | | [K251653](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K251653.md) | SPRY TMS Therapy System (0550) | Soterix Medical, Inc. | Feb 20, 2026 | SESE | | [K251391](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K251391.md) | BrainsWay Deep TMS System | Brainsway , Ltd. | Nov 7, 2025 | SESE | | [K250689](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K250689.md) | CloudTMS Edge | Teleemg, LLC | Sep 14, 2025 | SESE | | [K251449](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K251449.md) | BrainsWay Deep TMS System | Brainsway , Ltd. | Sep 13, 2025 | SESE | | [K243700](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K243700.md) | Apollo TMS Therapy System | Mag & More GmbH | Sep 4, 2025 | SESE | | [K243539](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K243539.md) | Apollo TMS Therapy System | Mag & More GmbH | Aug 18, 2025 | SESE | | [K251125](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K251125.md) | MagVenture TMS Therapy System | Tonica Elektronik A/S | Aug 11, 2025 | SESE | | [K251119](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K251119.md) | MagVenture TMS Therapy System | Tonica Elektronik A/S | Aug 8, 2025 | SESE | | [K252032](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K252032.md) | T65 (9016E061-) | Tonica Elektronik A/S | Jul 30, 2025 | SESE | | [K251210](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K251210.md) | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | Jun 27, 2025 | SESE | | [K243460](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K243460.md) | Ultimate rTMS | Brain Ultimate, Inc. | Apr 17, 2025 | SESE | | [K243869](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K243869.md) | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) | The Magstim Company Limited | Mar 17, 2025 | SESE | | [K243319](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K243319.md) | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | Feb 13, 2025 | SESE | | [K241518](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K241518.md) | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) | The Magstim Company Limited | Aug 30, 2024 | SESE | | [K222196](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K222196.md) | Deep TMS System | Brainsway , Ltd. | May 31, 2024 | SESE | | [K232639](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K232639.md) | Apollo TMS Therapy System | Mag & More GmbH | May 24, 2024 | SESE | | [K231926](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K231926.md) | NeuroStar Advanced Therapy System (All previously cleared models) | Neuronetics, Inc. | Mar 22, 2024 | SESE | | [K233631](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP/K233631.md) | ZapStim Controller Application (Z1023) | Revital Lab, Inc. | Feb 9, 2024 | SESE | ## Top Applicants - Tonica Elektronik A/S — 9 clearances - Brainsway , Ltd. — 8 clearances - Magstim Company, Ltd. — 8 clearances - Neuronetics, Inc. — 7 clearances - Neuronetics — 6 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OBP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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