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FDA 510(k)

Deep Transcranial Magnetic Stimulation (DTMS) System

K-Number: K210201 · 2021-08-17

ApplicantBrainsway , Ltd.
Decision Date2021-08-17
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Deep Transcranial Magnetic Stimulation (DTMS) System is a medical device manufactured by Brainsway , Ltd.. It received FDA 510(k) clearance on 2021-08-17 under approval number K210201. 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 Deep Transcranial Magnetic Stimulation (DTMS) System?

Deep Transcranial Magnetic Stimulation (DTMS) System is a medical device that received FDA 510(k) clearance on 2021-08-17. It is manufactured by Brainsway , Ltd.. The 510(k) number is K210201.

When was Deep Transcranial Magnetic Stimulation (DTMS) System approved by the FDA?

Deep Transcranial Magnetic Stimulation (DTMS) System received FDA 510(k) clearance on 2021-08-17, under approval number K210201.

What company makes Deep Transcranial Magnetic Stimulation (DTMS) System?

Deep Transcranial Magnetic Stimulation (DTMS) System is manufactured by Brainsway , Ltd..

What is the FDA product code for Deep Transcranial Magnetic Stimulation (DTMS) System?

The FDA product code for Deep Transcranial Magnetic Stimulation (DTMS) System is OBP.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT05460676 Reducing Tobacco Smoking: a Transcranial Direct Current Stimulation (TDCS) Telehealth Study COMPLETED NCT06868914 Phase I Trial of High-Density Theta Burst Stimulation (hdTBS) NOT_YET_RECRUITING NCT07615387 Electrophysiological Biomarkers in Accelerated TMS for Depression COMPLETED NCT06577454 Measuring the Effects of Neurostimulation on Risky and Ambiguous Decision-Making Capacity in People With and Without Substance Use Disorder SUSPENDED

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026)

Other Devices by Brainsway , Ltd.

K173540Brainsway Deep (DTMS) System K183303Brainsway Deep TMS System K200957Brainsway Deep TMS System K203735Brainsway Deep TMS System K203616Brainsway Deep (DTMS) System K220819BrainsWay Deep TMS System

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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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