Cleared Traditional

HORIZON TMS Therapy System

K182853 · Magstim Company, Ltd. · Neurology

Mar 2019

Decision

156d

Days

Class 2

Risk

About This 510(k) Submission

K182853 is an FDA 510(k) clearance for the HORIZON TMS Therapy System, 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 15, 2019, 156 days after receiving the submission on October 10, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number	K182853 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 10, 2018
Decision Date	March 15, 2019
Days to Decision	156 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.