Cleared Traditional

MagVenture TMS Therapy ? for treatment of OCD, MagVenture TMS Therapy system

K193006 · Tonica Elektronik A/S · Neurology

Aug 2020

Decision

286d

Days

Class 2

Risk

About This 510(k) Submission

K193006 is an FDA 510(k) clearance for the MagVenture TMS Therapy ? for treatment of OCD, MagVenture TMS Therapy system, a Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder (Class II — Special Controls, product code QCI), submitted by Tonica Elektronik A/S (Farum, DK). The FDA issued a Cleared decision on August 9, 2020, 286 days after receiving the submission on October 28, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5802.

Submission Details

510(k) Number	K193006 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 2019
Decision Date	August 09, 2020
Days to Decision	286 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	QCI — Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5802
Definition	External Device That Uses Magnetic Fields To Induce Neural Activity In The Cerebral Cortex To Treat Neurological And Psychiatric Disorders And Conditions. It Is Not Intended For Applying Or Focusing Magnetic Fields Towards Brain Areas Outside Cerebral Cortex (e.g., Cerebellum).