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510(k) Data Aggregation

    K Number
    K223027
    Device Name
    NeuroTrigger Basic (NTB)
    Manufacturer
    Date Cleared
    2023-10-10

    (376 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    NeuroTrigger

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NeuroTrigger Basic is indicated for the prevention of disuse atrophy, muscle re-education, and for maintaining or increasing range of motion.
    Device Description
    The NeuroTrigger Basic (NTB) powered muscle stimulator is composed of a hardware component encased in Acrylonitrile Butadiene Styrene (ABS) plastic that attaches to the body with double-sided tape (DST) and delivers electrical stimulation to different body regions through a single use/disposable pre-gelled Y-shaped electrode. The Y-shaped electrodes consist of a PET base, with silver/silver chloride conductive ink, covered by a double coated medical polyethylene DST film, and hydrogel circles at the center of the Y heads. The NTB System is made up of the following components and accessories: Main components: - Stimulator - Electrodes - Android app Accessories: - Stimulator holder, with double-sided adhesive stickers - Charging cradle - USB-C charge cable - AC/DC Charger The NTB stimulator contains embedded software that controls the generation of the stimulation signals, provides current measurement circuitry to monitor the delivered current, provides a Bluetooth Low Energy (BLE) wireless communication with remote control SW running on Android based App. The electrical stimulation is delivered to different body regions through the 2 electrode sizes (either wide or narrow span electrodes). The stimulator is stored in the NTB charging cradle, the housing case for the device, when not in use. Both components (the stimulator and the cradle) are made of ABS, but the NTB stimulator contains a PCB board and a lithium battery, and fits into the cradle by magnetized coupling and is held in place with pogo pins. The cradle acts as a charging station for the stimulator in addition to being a housing storage unit. The cradle, built of two parts, contains magnets that allow for the single axis magnetic opening and closure of the case. The AC/DC charger connects to the cradle through the USB C cable during charging cycles, which is when the stimulator is not in use. The stimulator holder is supplied to allow for different body region uses, and is also made from ABS material and can be attached to different bodily regions with DST. The cradle and stimulator display different indications (i.e. BLE pairing, connection state, battery status) through LED lights. NTB user setup is performed under the guidance and instruction of a supervising physician and is controlled wirelessly from the Android smartphone-based mobile application (Bluetooth connection to the stimulator). The stimulator contains embedded software that generates controllable stimulation signal for stimulating nerves and muscles. The stimulation signal parameters can be controlled by special application over Bluetooth Low Energy (BLE) connection. Communication with the stimulator host application is done over BLE, data are encrypted with the standard BLE pairing and encryption/decryption that is done at the BLE level. The SW is a remote control application installed on portable Android device with support to BLE 4.2 and above to control the HW and serve as UI. Secured login mechanism is implemented on the application to prevent unsecured using of the application also to protect patient's personal information and details The application supports three types of users: - Patients - Clinicians - Administrators The SW is programmed to show the following LEDs/Display indications for general functions: - On/off - Low power - Effective electrode contact coupling - Application coupling
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