Cleared Traditional

Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+

K223154 · Magstim Company, Ltd. · Neurology
Mar 2023
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K223154 is an FDA 510(k) clearance for the Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+, a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP), submitted by Magstim Company, Ltd. (Whitland, GB). The FDA issued a Cleared decision on March 16, 2023, 161 days after receiving the submission on October 6, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number K223154 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 2022
Decision Date March 16, 2023
Days to Decision 161 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.