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FDA 510(k)

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®

K-Number: K233293 · 2024-01-16

ApplicantNeurosigma, Inc.
Decision Date2024-01-16
Product CodeQGL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® is a medical device manufactured by Neurosigma, Inc.. It received FDA 510(k) clearance on 2024-01-16 under approval number K233293. The device is classified under product code QGL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®?

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® is a medical device that received FDA 510(k) clearance on 2024-01-16. It is manufactured by Neurosigma, Inc.. The 510(k) number is K233293.

When was Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® approved by the FDA?

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® received FDA 510(k) clearance on 2024-01-16, under approval number K233293.

What company makes Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®?

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® is manufactured by Neurosigma, Inc..

What is the FDA product code for Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®?

The FDA product code for Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® is QGL.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT04935697 Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress COMPLETED NCT07517172 Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 41470022 Low-intensity pulsed ultrasound for peripheral nerve regeneration: mechanobiological mechanisms and translational potential. Journal of translational medicine (2025) PMID: 41443207 Artificial Intelligence in UK Hospital Medicine: From Innovation to Implementation. British journal of hospital medicine (London, England : 2005) (2025)

Other Devices by Neurosigma, Inc.

DEN180041Monarch eTNS System

Related Devices (Code: QGL)

DEN180041Monarch eTNS SystemNeurosigma, Inc. K213629SMILENu Eyne Co., Ltd. K232991BT-1000Bistos Co., Ltd. K243289ADDNOX (BPSPM1)Nu Eyne Co., Ltd.

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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