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510(k) Data Aggregation

    K Number
    K260455

    Validate with FDA (Live)

    Device Name
    New Wave System
    Manufacturer
    Zeto, Inc.
    Date Cleared
    2026-03-13

    (30 days)

    Product Code
    GWQ
    Regulation Number
    882.1400
    Type
    Special
    Panel
    Neurology
    Age Range
    2 - 120
    Reference & Predicate Devices
    K233403
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The New Wave system is intended for prescription use in an outpatient healthcare facility or home use to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The New Wave system acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), orientation sensor data, photic sensor data, external trigger signals, and video. The system is only intended to be used for short-term recordings up to 2.5 hours.

    Device Description

    The New Wave System is intended to acquire, analyze, transmit, display and store primarily EEG and optionally auxiliary signals. The New Wave is designed to perform EEG using 19 signal electrodes and 1 dedicated active ground/driven-right-leg (DRL) electrode, adjusted and placed to comply with the 10-20 EEG system.

    The device consists of the following components:

    • Head Unit
    • Electrodes
    • Charger
    • Display Unit
    • Extension Unit
    • Lead wires
    • Software and Zeto Cloud Platform (ZCP)
      • Firmware and Display Unit software
      • Data center application
      • Client application
    AI/ML Overview

    N/A

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