Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K162460
    Device Name
    WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts
    Manufacturer
    Date Cleared
    2017-04-28

    (238 days)

    Product Code
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAVI, CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The WAV Headset is intended for use in routine clinical and research settings where rapid placement of a number of EEG electrodes is desired.
    Device Description
    The WAVI™ Headset is an EEG electrode positioning system used to quickly place the electrodes in a uniform and consistent manner in accordance with the international standard Ten-Twenty System (10-20) to acquire electrophysiological EEG signals from an individual to a suitable EEG data collection device. The device consists of the WAVi™ Headset, WAVi™ eSoc™ Single Use and Tin Electrode Contacts; the head set comes in five models/sizes (XS, S, M, L, XL). This device is portable, nonsterile, non-invasive, non-radiation emitting, point-of-care use device for use in healthcare facilities and hospitals. Device characteristics include the eSoc™ Single Use Electrode Contacts which are soaked in 0.9% Normal Saline which is unique as it serves as the electro-conductive material and patient contact allowing the brain's electrical signals to be read through an EEG data collection device. Typical set-up and procedure time is less than twenty minutes. The device does not contain software, biologics, drugs, coatings or any claim of sterility. The WAVI™ Headset, eSoc™ Single Use and Ear Electrode Contacts are made from wellestablished medical grade materials; the Headset is made from a proprietary EVA material with tin plated ring electrode ports for placement of the Nylon 101 WAVi™ eSoc™ Single Use Electrode Contacts, and two ear electrodes are also made from Tin. A wire harness is embedded between two layers of EVA and is attached to each electrode port. The wire harness exits the headset to a 32-pin connector port.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1