Cleared Traditional

Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation

K211389 · Magstim Company, Ltd. · Neurology

Sep 2021

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K211389 is an FDA 510(k) clearance for the Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation, 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 September 14, 2021, 132 days after receiving the submission on May 5, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number	K211389 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 05, 2021
Decision Date	September 14, 2021
Days to Decision	132 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.