OBP · Transcranial Magnetic Stimulator

Device class

Class II

Regulation 882.5805

Total clearances

2020-11-20 → 2026-09-06

Last 12 months

Unique sponsors

Definition

What is Transcranial Magnetic Stimulator

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.

Classification details

Medical specialty

Neurology

Review panel

Regulation number

882.5805

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Neuronetics, Inc.	7	0	2024-03-22
Brainsway , Ltd.	6	1	2025-11-07
Tonica Elektronik A/S	4	1	2026-05-22
Mag & More GmbH	4	1	2026-05-22
Magstim Company, Ltd.	3	0	2023-03-16
Brain Ultimate, Inc.	3	1	2026-08-14
Nexstim Oyj	2	2	2026-03-20
Neuromodulatory Devices & Applications	2	0	2025-06-27
The Magstim Company Limited	2	0	2025-03-17
Remed Co., Ltd.	2	0	2022-04-06
BTL Industries, Inc.	2	1	2026-08-23
Teleemg, LLC	1	0	2025-09-14
Neuroqore, Inc.	1	0	2023-12-29
Magnus Medical, Inc.	1	0	2022-09-01
The Magstim Company , Ltd.	1	0	2023-10-25
Fidelity BioPharma Co.	1	1	2026-09-06
Revital Lab, Inc.	1	0	2024-02-09
Soterix Medical, Inc.	1	1	2026-02-20

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
90867	CPT	—	High	Repetitive transcranial magnetic stimulation; standard CPT for TMS therapy
90868	CPT	—	High	Repetitive transcranial magnetic stimulation with complex motor or cognitive testing

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-06	K260396	Fidelity BioPharma Co.	KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)
2026-08-23	K260691	BTL Industries, Inc.	BTL-699
2026-08-14	K261228	Brain Ultimate, Inc.	QuickVision Ultimate rTMS
2026-05-22	K260560	Mag & More GmbH	Apollo TMS Therapy System;Apollo light TMS Therapy System
2026-05-22	K260189	Tonica Elektronik A/S	MagVenture Accelerated TMS (aTMS) Therapy System
2026-03-20	K253098	Nexstim Oyj	Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
2026-03-20	K252358	Nexstim Oyj	Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
2026-02-20	K251653	Soterix Medical, Inc.	SPRY TMS Therapy System (0550)
2025-11-07	K251391	Brainsway , Ltd.	BrainsWay Deep TMS System
2025-09-14	K250689	Teleemg, LLC	CloudTMS Edge
2025-09-13	K251449	Brainsway , Ltd.	BrainsWay Deep TMS System
2025-09-04	K243700	Mag & More GmbH	Apollo TMS Therapy System
2025-08-18	K243539	Mag & More GmbH	Apollo TMS Therapy System
2025-08-11	K251125	Tonica Elektronik A/S	MagVenture TMS Therapy System
2025-08-08	K251119	Tonica Elektronik A/S	MagVenture TMS Therapy System
2025-07-30	K252032	Tonica Elektronik A/S	T65 (9016E061-)
2025-06-27	K251210	Neuromodulatory Devices & Applications	Ampa One System (AMPA-001)
2025-04-17	K243460	Brain Ultimate, Inc.	Ultimate rTMS
2025-03-17	K243869	The Magstim Company Limited	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)
2025-02-13	K243319	Neuromodulatory Devices & Applications	Ampa One System (AMPA-001)
2024-08-30	K241518	The Magstim Company Limited	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)
2024-05-31	K222196	Brainsway , Ltd.	Deep TMS System
2024-05-24	K232639	Mag & More GmbH	Apollo TMS Therapy System
2024-03-22	K231926	Neuronetics, Inc.	NeuroStar Advanced Therapy System (All previously cleared models)
2024-02-09	K233631	Revital Lab, Inc.	ZapStim Controller Application (Z1023)