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510(k) Data Aggregation

    K Number
    K243289
    Device Name
    ADDNOX (BPSPM1)
    Manufacturer
    Date Cleared
    2025-01-16

    (90 days)

    Product Code
    Regulation Number
    882.5898
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nu Eyne Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    K242719
    Device Name
    ELEXIR 2.0 (ALLIVE3)
    Manufacturer
    Date Cleared
    2024-11-06

    (57 days)

    Product Code
    Regulation Number
    882.5891
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nu Eyne Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ELEXIR 2.0 is indicated for the acute treatment of migraine (Acute mode, frequency 100 Hz) and the prophylactic treatment of episodic migraine (Prevention mode, frequency 60 Hz) in patients 18 years of age or older.
    Device Description
    The ELEXIR 2.0 is a transcutaneous electrical nerve stimulator (TENS) that is applied to the forehead using a self-adhesive electrode positioned over the upper branches of the trigeminal nerve bilaterally. It is intended to stimulate the upper branches of the trigeminal nerve in order to reduce the frequency of migraine attack. The ELEXIR 2.0 is indicated for the acute treatment of migraine and the prophylactic treatment of episodic migraine by applying 100 Hz (Acute mode) and 60 Hz (Prevention mode), low-frequency stimulation to the forehead area percutaneously to the trigeminal nerve.
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    K Number
    K213629
    Device Name
    SMILE
    Manufacturer
    Date Cleared
    2023-02-12

    (452 days)

    Product Code
    Regulation Number
    882.5898
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nu Eyne Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    K211380
    Device Name
    Elexir
    Manufacturer
    Date Cleared
    2021-07-30

    (87 days)

    Product Code
    Regulation Number
    882.5891
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nu Eyne Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    THE ELEXIR is indicated for the acute treatment of migraine (program 1) and the prophylactic treatment of episodic migraine (Program 2) in patients 18 years of age or older
    Device Description
    The ELEXIR device is a transcutaneous electrical nerve stimulator (TENS) that is applied to the forehead using a self-adhesive electrode positioned over the upper branches of the trigeminal verve bilaterally. It is intended to stimulate the upper branches of the trigeminal verve in order to reduce the frequency of migraine attack.
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    K Number
    K192773
    Device Name
    ALLIVE
    Manufacturer
    Date Cleared
    2019-12-06

    (67 days)

    Product Code
    Regulation Number
    882.5891
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nu Eyne Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Allive is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
    Device Description
    The Allive device is a transcutaneous electrical nerve stimulator (TENS) that is applied to the forehead using a self-adhesive electrode positioned over the upper branches of the trigeminal verve bilaterally. It is intended to stimulate the upper branches of the trigeminal verve in order to reduce the frequency of migraine attack.
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