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510(k) Data Aggregation
K Number
K233293Device Name
Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
Manufacturer
NeuroSigma, Inc.
Date Cleared
2024-01-16
(109 days)
Product Code
QGL
Regulation Number
882.5898Why did this record match?
Applicant Name (Manufacturer) :
NeuroSigma, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® ("Monarch Gen 2") is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
Device Description
The Monarch Gen 2 eTNS System is a non-invasive device that uses electrical signals to therapeutically stimulate the Trigeminal nerve. The primary components of the device are:
- . The Monarch® Gen 2 external pulse generator, which controls the electrical stimulation, and
- The Monarch® NS-2 external (cutaneous) electrical patches, which are single-use disposable patches worn on the forehead (Figure 3).
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K Number
DEN180041Device Name
Monarch eTNS System
Manufacturer
NeuroSigma, Inc
Date Cleared
2019-04-19
(263 days)
Product Code
QGL, OGL
Regulation Number
882.5898Why did this record match?
Applicant Name (Manufacturer) :
NeuroSigma, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Monarch external Trigeminal Nerve Stimulation (eTNS) System is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
Device Description
The Monarch external Trigeminal Nerve Stimulation (eTNS) System is a non-invasive device that uses electrical signals to therapeutically stimulate the Trigeminal nerve. The primary components of the device are:
- The Monarch external pulse generator
- The Monarch NS-2 external (cutaneous) electrical patches, which are single use disposable patches worn on the forehead.
The device has two primary components A) an external pulse generator approximately the size of a cell phone, and B) the non-invasive electrical patch that patients apply to their forehead to receive therapy.
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