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510(k) Data Aggregation

    K Number
    K232253
    Device Name
    Modius Stress
    Date Cleared
    2024-03-27

    (243 days)

    Product Code
    Regulation Number
    882.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neurovalens Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Modius Stress is a non-invasive, home-use neurostimulation device that is indicated to treat the symptoms of Generalized Anxiety Disorder in adults aged 22 and older, when used for approximately 4 weeks. Durability of effect after 4 weeks has not been established.
    Device Description
    Modius Stress is a non-invasive transdermal neurostimulation device to treat the symptoms of Generalized Anxiety Disorder. The proposed mechanism of the device is through a technology known as Cranial Electrotherapy Stimulation (CES). It consists of a battery-powered device designed to transcutaneously deliver low-level electrical energy (up to 1.5mA) to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads. These pads are placed on the skin behind each ear (mastoid area). The intensity of the electric pulse can be adjusted up or down by the user. When turned on, the device delivers a small electrical impulse, and adjustments to the stimulation level may be made using the up and down buttons on the device, which are located just above the power button. The device can also be paused by pressing the power button twice. When finished the user removes the device and disposes of the electrode pads after each use. When the device is not being used it can be charged through a micro-USB cable. For safety reasons, it is not possible to recharge the battery while the device is in use in stimulation mode. The key components of the Modius Stress include the Modius Stress device (plastic enclosure and printed circuit board assembly (PCBA), stimulation pads (K210448 and K132588), skin cleansing wipes (K121655) and charging accessories. The PCBA consists of a microcontroller, USB connector, transformer driver, IO expander and EEPROM memory. The embedded software within the device manages overall functionality of the device from Stimulation Control, Power Management, and user interaction (Indication LED and Audio tones).
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    K Number
    K230826
    Device Name
    Modius Sleep
    Manufacturer
    Date Cleared
    2023-10-27

    (217 days)

    Product Code
    Regulation Number
    882.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neurovalens Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Modius Sleep is a non-invasive, home-use neurostimulation device to treat chronic insomnia in adults aged 22 and older.
    Device Description
    Modius Sleep is a low-risk non-invasive transdermal neurostimulation device to treat chronic insomnia. The proposed mechanism of the device is through a technology known as electrical vestibular nerve stimulation (VeNS). It consists of a battery-powered device designed to transcutaneously deliver low-level electrical energy (up to 1mA) to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads. These pads are placed on the skin behind each ear (mastoid area). The intensity of the electric pulse can be adjusted up or down by the user. When turned on, the device delivers a small electrical impulse which stimulates the vestibular nerve. Adjustments to the stimulation level may be made using the up and down buttons on the device, which are located just above the power button. The device can also be paused by pressing the power button twice. When finished the user removes the device and disposes of the electrode pads after each use. When the device is not being used it can be charged through a micro-USB cable. For safety reasons, it is not possible to recharge the battery while the device is in use in stimulation mode. The key components of the Modius Sleep include the Modius Sleep device (plastic enclosure and printed circuit board assembly (PCBA), stimulation pads (K210448 and K132588), skin cleansing wipes (K121655) and charging accessories. The PCBA consists of a microcontroller, USB connector (charging only), transformer driver, IO expander and EEPROM memory. The embedded software within the device manages overall functionality of the device from Stimulation Control, Power Management, and user interaction (Indication LED and Audio tones).
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    K Number
    K083679
    Device Name
    UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1
    Manufacturer
    Date Cleared
    2009-09-11

    (274 days)

    Product Code
    Regulation Number
    890.1375
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROVAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To acquire EMG signals for display and analysis by, or under the direction of a health care professional, to assess neurogenic sacral dysfunction such as urinary incontinence and fecal incontinence.
    Device Description
    The UroVal BRS System is used to record and display electromyogram (EMG) signals. In addition, the BRS System will determine latency time intervals of the bulbocavernous reflex (BCR). The UroVal BRS System also has report generation capabilities. The UroVal BRS System uses a probe, with a single use disposable tip to evoke a BCR response, and activate recording and timing of EMG signals. The UroVal BRS System uses pregelled surface electrodes to monitor the muscle activity.
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