Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K182311
    Device Name
    Cervella
    Manufacturer
    Innovative Neurological Devices LLC
    Date Cleared
    2019-03-07

    (195 days)

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

    Innovative Neurological Devices LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cervella Cranial Electrotherapy Stimulator (CES) is indicated for treatment of insomnia, depression, or anxiety.
    Device Description
    Cervella Cranial Electrotherapy Stimulator (CES) is a device that delivers small pulses of electrical current through patient's brain. The stimulator is powered by an internal rechargeable battery which provides a low-level constant current to the cranium via a pair of conductive electrodes placed bilaterally on the mastoid process. The electrodes are incorporated into earpads of stereo over-ear noise-cancelling headphones. The patient can use the audio (through a separate dedicated Bluetooth connection) and noise cancelling features of the stereo headphones during treatment (e.g. music listening). The stimulator is controlled via a software application (app) installed on the patient's smart device (e.g. smartphone). The app communicates with the device through a dedicated Bluetooth® LE connection that is independent of the optional Bluetooth connection for audio listening purposes. The patient uses the app to adjust the intensity level, frequency, and duration of the treatment. The app also allows the patient to automatically store the treatment history for review by the patient's healthcare provider.
    Ask a Question

    Page 1 of 1