Cleared Traditional

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)

K243869 · The Magstim Company Limited · Neurology
Mar 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K243869 is an FDA 510(k) clearance for the 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), a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP), submitted by The Magstim Company Limited (Carmarthenshire, GB). The FDA issued a Cleared decision on March 17, 2025, 90 days after receiving the submission on December 17, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number K243869 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2024
Decision Date March 17, 2025
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OBP — Transcranial Magnetic Stimulator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5805
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.