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

FDA 510(k)

MagVita TMS Therapy System

K-Number: K171481 · 2017-06-16

ApplicantTonica Elektronik A/S
Decision Date2017-06-16
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MagVita TMS Therapy System is a medical device manufactured by Tonica Elektronik A/S. It received FDA 510(k) clearance on 2017-06-16 under approval number K171481. 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 MagVita TMS Therapy System?

MagVita TMS Therapy System is a medical device that received FDA 510(k) clearance on 2017-06-16. It is manufactured by Tonica Elektronik A/S. The 510(k) number is K171481.

When was MagVita TMS Therapy System approved by the FDA?

MagVita TMS Therapy System received FDA 510(k) clearance on 2017-06-16, under approval number K171481.

What company makes MagVita TMS Therapy System?

MagVita TMS Therapy System is manufactured by Tonica Elektronik A/S.

What is the FDA product code for MagVita TMS Therapy System?

The FDA product code for MagVita TMS Therapy System is OBP.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

Other Devices by Tonica Elektronik A/S

K160280MagPro R20 K172667MagVita TMS Therapy w/MagPro R20 K171967MagVita TMS Therapy System K170114MagVita TMS Therapy - w/MagPro R20 K162873MEP Monitor K173620Mag Vita TMS Therapy System w/Theta Burst Stimulation

View all 13 devices →

Related Devices (Code: OBP)

K160309Neurosoft TMSTeleemg, LLC K161519NeuroStar TMS Therapy SystemNeuronetics, Inc. K160703NeuroStar TMS Therapy SystemNeuronetics, Inc. K173441Neurosoft TMS (also CloudTMS)Teleemg, LLC K171902Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc K172667MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S

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.

↑