Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K193006 · 2020-08-09

ApplicantTonica Elektronik A/S
Decision Date2020-08-09
Product CodeQCI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system is the device name listed in this FDA 510(k) record. The listed applicant is Tonica Elektronik A/S. It received FDA 510(k) clearance on 2020-08-09 under 510(k) number K193006. The device is classified under product code QCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system?

MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system is a medical device that received FDA 510(k) clearance on 2020-08-09. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K193006.

When did MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system receive FDA 510(k) clearance?

MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system received FDA 510(k) clearance on 2020-08-09, under 510(k) number K193006.

Who is the listed applicant for MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system?

The FDA 510(k) record lists Tonica Elektronik A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system?

The FDA product code for MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system is QCI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07587112Explore Neural Mechanism of Obsessive-Compulsive Disorder (OCD) by Intervention of Repetitive Transcranial Magnetic Stimulation With Symptom ProvocationRECRUITING

Other records listing Tonica Elektronik A/S as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260189MagVenture Accelerated TMS (aTMS) Therapy SystemK251125MagVenture TMS Therapy SystemK251119MagVenture TMS Therapy SystemK252032T65 (9016E061-)K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOptionK221544MagVenture TMS Atlas Neuro Navigation System

View all 14 devices →

Related Devices (Code: QCI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260402MeRT SystemWave NeuroscienceK243459Ultimate rTMS for OCD (M-series)Brain Ultimate, Inc.K230657BTL-99-OCBTL Industries, Inc.K233742CloudTMS Edge for OCDTeleemg, LLCK231350OCD MT Cap (85-00397-000)NeuroneticsK221129CloudTMS for OCDTeleemg, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑