OBPClass II

Transcranial Magnetic Stimulator

21 CFR 882.5805 / Neurology

OBP is the FDA product code for Transcranial Magnetic Stimulator, a class II device type, regulated under 21 CFR 882.5805. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 68 510(k) clearances under this code, the most recent dated 2026-08-23, and 5 recalls.

Classification record

Product code: OBP
Device name: Transcranial Magnetic Stimulator
FDA 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.
Regulation: 21 CFR 882.5805
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 69
Ingested recalls: 5

Clearances, product code OBP

By decision year

69 clearances under product code OBP with a decision year between 2008 and 2026, 2025 the highest year at 12.

Show the numbers

510(k) clearances under FDA product code OBP by decision year
Year	Clearances
2008	2
2013	2
2014	1
2015	2
2016	3
2017	8
2018	4
2019	3
2020	1
2021	5
2022	6
2023	7
2024	5
2025	12
2026	8

Applicants with the most clearances

Product code OBP

Applicants holding the most 510(k) clearances under product code OBP
Applicant	Clearances
Neuronetics Inc.	13
Magstim Inc.	12
Tonica Elektronik a/S	10
Brainsway Ltd.	8
Mag & More GmbH	5
Brain Ultimate, Inc.	3
Teleemg, LLC	3
Neuromodulatory Devices & Applications	2
Nexstim Oyj	2
Nexstim Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order