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)

K241518 · The Magstim Company Limited · Neurology
Aug 2024
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K241518 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 August 30, 2024, 93 days after receiving the submission on May 29, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number K241518 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2024
Decision Date August 30, 2024
Days to Decision 93 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.