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FDA 510(k)

Mag Vita TMS Therapy System w/Theta Burst Stimulation

K-Number: K173620 · 2018-08-14

ApplicantTonica Elektronik A/S
Decision Date2018-08-14
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Mag Vita TMS Therapy System w/Theta Burst Stimulation 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 2018-08-14 under 510(k) number K173620. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mag Vita TMS Therapy System w/Theta Burst Stimulation?

Mag Vita TMS Therapy System w/Theta Burst Stimulation is a medical device that received FDA 510(k) clearance on 2018-08-14. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K173620.

When did Mag Vita TMS Therapy System w/Theta Burst Stimulation receive FDA 510(k) clearance?

Mag Vita TMS Therapy System w/Theta Burst Stimulation received FDA 510(k) clearance on 2018-08-14, under 510(k) number K173620.

Who is the listed applicant for Mag Vita TMS Therapy System w/Theta Burst Stimulation?

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 Mag Vita TMS Therapy System w/Theta Burst Stimulation?

The FDA product code for Mag Vita TMS Therapy System w/Theta Burst Stimulation is OBP.

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.

NCT06523439Accelerated Intermittent Theta Burst in Treatment-Naive AdolescentsRECRUITINGNCT06895863COpenhagen Magnetic Personalized Accelerated Brain Circuit Therapy for Treatment Resistant DepressionRECRUITINGNCT07171359TMS to Improve Recovery Outcomes Among Patients With Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD)RECRUITINGNCT07593222Synaptic Mechanisms of Intermittent Theta Burst Stimulation for Major Depressive DisorderNOT_YET_RECRUITINGNCT07745569Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic TherapiesNOT_YET_RECRUITINGNCT03121066Transcranial Magnetic Stimulation for Alzheimer's Disease TreatmentNOT_YET_RECRUITING

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: OBP)

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.

K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbHK260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/SK253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK251653SPRY TMS Therapy System (0550)Soterix Medical, Inc.

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.

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