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Generation 2.0 Monarch External Trigeminal Nerve Stimulation eTNS System

by Neurosigma, Inc.

510(k) K233293

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK233293 Date16 Jan 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QGL
Device Class
Class II
Regulation
21 CFR Part 882.5898
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System is a transcutaneous nerve stimulator indicated for the treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD). It functions by delivering gentle electrical pulses to the trigeminal nerve to influence brain function, mood, and attention.

This device is intended for use as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. It is supplied for use in the home by prescription only and has received FDA 510(k) clearance.

Other devices from Neurosigma, Inc.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the Monarch Generation 2.0 eTNS System?

    This device is indicated for the treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD). It is specifically intended for use as a monotherapy in patients between the ages of 7 and 12 years old who are not currently taking prescription ADHD medications.

  • How is the Monarch eTNS System administered?

    The system functions by delivering gentle electrical pulses to the trigeminal nerve to influence brain function, mood, and attention. It is supplied for use in the home environment and requires a prescription from a healthcare provider.

  • What is the regulatory status of this device?

    The Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System has received FDA 510(k) clearance under the product code QGL. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.