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FDA 510(k)

MagVenture TMS Therapy System

K-Number: K251119 · 2025-08-08

ApplicantTonica Elektronik A/S
Decision Date2025-08-08
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MagVenture TMS Therapy System is a medical device manufactured by Tonica Elektronik A/S. It received FDA 510(k) clearance on 2025-08-08 under approval number K251119. 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 MagVenture TMS Therapy System?

MagVenture TMS Therapy System is a medical device that received FDA 510(k) clearance on 2025-08-08. It is manufactured by Tonica Elektronik A/S. The 510(k) number is K251119.

When was MagVenture TMS Therapy System approved by the FDA?

MagVenture TMS Therapy System received FDA 510(k) clearance on 2025-08-08, under approval number K251119.

What company makes MagVenture TMS Therapy System?

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

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

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

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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 K171481MagVita TMS Therapy System K170114MagVita TMS Therapy - w/MagPro R20 K162873MEP Monitor

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.

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