Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K213623
    Device Name
    iTEAR100 Neurostimulator
    Date Cleared
    2022-03-16

    (120 days)

    Product Code
    Regulation Number
    886.5305
    Why did this record match?
    Product Code :

    QKV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iTEAR100 Neurostimulator is an electromechanical nerve stimulator device, indicated for temporary use (up to 30 days) to increase acute tear production during vibratory stimulation of the external nasal nerve in adults, under prescription of an eye care provider.
    Device Description
    The iTEAR100 device is a prescription only, non-implantable, electromechanical stimulator intended to increase tear production acutely (over 30 days) through vibratory stimulation of the external nasal nerve in adult patients. The device's technological principle is the application of mechanical vibration to specific sensory neurons on the side of the nose. The device is battery-operated with a single vibratory tip. As the tip is pushed against the tissue, the beam deflects inward until it is deflected fully into the device consists of a handheld unit with a plastic shell, power button, charging port, and effector tip accessible from the exterior. The interior includes mechanical and electrical subsystems comprised of a motor, supercapacitor, printed circuit board assembly (PCBA) including driver board, control board and Bluetooth microprocessor, vibrating cantilever beam attached to the effector tip, and real-time clock. The iTEAR100 Neurostimulator connects via Bluetooth Low Energy to a mobile application downloaded onto the user's mobile device (compatible with iOS or Android operating system). The mobile application is necessary to activate the device for initial use and collects device usage data which the user may upload to a cloud database at the user's discretion.
    Ask a Question

    Ask a specific question about this device

    K Number
    DEN190026
    Device Name
    iTEAR Neurostimulator
    Date Cleared
    2020-05-01

    (352 days)

    Product Code
    Regulation Number
    886.5305
    Why did this record match?
    Product Code :

    QKV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iTEAR100 Neurostimulator is an electromechanical nerve stimulator device, indicated for temporary use (up to 30 days) to increase acute tear production during vibratory stimulation of the external nasal nerve in adults, under prescription of an eye care provider.
    Device Description
    iTEAR100 Neurostimulator is a hand-held, portable electromechanical actuator intended to acutely increase tear production through vibratory stimulation of the external nasal nerve in patients. The device is battery-operated with a single vibratory tip. As the effective tip is pushed against the tissue, the beam deflects inward until it is deflected fully into the device. The device is comprised of a direct current vibration motor, vibrating beam(cantilever), a control circuit with micro SD card, tactile switch. The motor is attached to a cantilever beam made from acrylonitrile butadiene styrene (ABS), a control circuit to charge the battery and deliver power to the motor, and a housing also made from ABS. The motor and cantilever beam move together to produce a linear vibration at the tip of the cantilever (oscillating tip). A lithium-ion rechargeable battery is supplied inside the device, and is not removable or replaceable. A micro USB port on the device allows for charging. The device is locked by firmware from use after a predetermined number of stimulation days has been triggered.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1