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510(k) Data Aggregation
K Number
K243289Device Name
ADDNOX (BPSPM1)
Manufacturer
Nu Eyne Co., Ltd.
Date Cleared
2025-01-16
(90 days)
Product Code
QGL
Regulation Number
882.5898Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ADDNOX is indicated for the 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 ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.
Device Description
The ADDNOX is a transcutaneous electrical trigeminal nerve stimulator for Attention Deficit Hyperactivity Disorder. It is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.
The ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.
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K Number
K232991Device Name
BT-1000
Manufacturer
Bistos Co., Ltd.
Date Cleared
2024-08-28
(341 days)
Product Code
QGL, OGL
Regulation Number
882.5898Why did this record match?
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Matched: '882.5898'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BT-1000 external Trigeminal Nerve Stimulation System 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 to be 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
Electrical stimulator that alleviate the symptoms of Attention Deficit Hyperactivity Disorder (ADHD), a psychological mental disorder, by non-invasively stimulating cranial nerves with fine electrical stimulation using extracorporeal electrodes. The treatment protocol using the BT-1000 is administered each night while the patient is sleeping, for 7-9 hours. The device is designed to provide non-invasive electrical stimulation of the trigeminal nerve via an electrode placed on the forehead.
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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?
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Matched: '882.5898'
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
K213629Device Name
SMILE
Manufacturer
Nu Eyne Co., Ltd.
Date Cleared
2023-02-12
(452 days)
Product Code
QGL, OGL
Regulation Number
882.5898Why did this record match?
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Matched: '882.5898'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SMILE external Trigeminal Nerve Stimulation (eTNS) System 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 to be 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
Transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder. A transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.
The SMILE eTNS System treatment protocol is administered each night while the patient is sleeping, for 7-9 hours. The device is designed to provide non-invasive electrical stimulation of the trigeminal nerve.
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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?
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Matched: '882.5898'
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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