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FDA PRODUCT CODE · CLASS II

OBP — 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.

DEVICE CLASS
Class II
REGULATION
21 CFR 882.5805
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
17
510(K)/PMA CLEARANCES
510k: 17
0
RECALL ENTRIES

Recent clearances

K260560Mag & More GmbH · 510k2026-05-22
K260189Tonica Elektronik A/S · 510k2026-05-22
K253098Nexstim Oyj · 510k2026-03-20
K252358Nexstim Oyj · 510k2026-03-20
K251653Soterix Medical, Inc. · 510k2026-02-20
K251391Brainsway , Ltd. · 510k2025-11-07
K250689Teleemg, LLC · 510k2025-09-14
K251449Brainsway , Ltd. · 510k2025-09-13

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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