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510(k) Data Aggregation

    K Number
    K230526
    Device Name
    TEA Device
    Manufacturer
    Transtimulation Research, Inc.
    Date Cleared
    2023-09-14

    (199 days)

    Product Code
    QHH
    Regulation Number
    876.5340
    Why did this record match?
    Applicant Name (Manufacturer) :

    Transtimulation Research, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transcutaneous Electrical Applicator (TEA) is a transcutaneous electrical nerve field stimulator system intended to be used in adult patients with functional abdominal pain associated with irritable bowel syndrome (IBS) through application to Cranial Nerves V, VI, IX and X, and the occipital nerves, as an aid in the reduction of pain when combined with other therapies for IBS. TEA device is intended to be used for 7-120 hours per week up to 3 consecutive weeks.
    Device Description
    The TEA Device is a non-invasive, battery-operated, prescription-based transcutaneous electrical nerve field stimulator indicated for use in adult patients with functional abdominal pain associated with the irritable bowel syndrome (IBS). The system includes the following components: TEA Device, lead cable, USB charging cable, USB power adapter, electrode pads, holding clip, and TEA IBS app. The device can be used in clinical environments (i.e., outpatient clinics and hospitals) and/or at home. The TEA Device is powered by an internal rechargeable lithium polymer battery and uses a microprocessor to control the working modes, the waveform and strength of the output pulse. The electric pulse generator is based on a current source circuit. The power management module contains a DC-DC boost conversion circuit that provides the required voltage for the electric pulse generator. The TEA Device is able to connect with the TEA IBS app, which is located on a smartphone. The user interface is available on both the TEA Device and TEA IBS app. The user can power on/off the device, adjust treatment time and treatment intensity. Treatment time is adjustable within the of range 5~240 minutes per treatment session with a maximal operating time of 8.6 hours per day. In addition, there is over-load, over-current and no-load protection as well as an automatic shut-off function. The Bluetooth transceiver module is responsible for communication between the TEA Device and TEA IBS app located on a smartphone.
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