BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TruScan Neurofeedback Explorer

    Reg #: 3015497638 · FEI: 3015497638 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RONAN MEDICAL LLC
    Registration Number
    3015497638
    FEI Number
    3015497638
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3630 Sinton Road, Suite 100
    City
    Colorado Springs
    State
    CO
    ZIP
    80907
    Country
    US

    Owner / Operator

    Firm Name
    Ronan Medical
    Operator Number
    10060568
    Address
    3630 Sinton Road, Suite 100
    City
    Colorado Springs
    State
    CO
    Postal Code
    80907
    Country
    US
    Correspondent
    Doug E Youngberg

    Products

    Device Name Product Code
    Device, Biofeedback HCC

    Proprietary Names

    TruScan Neurofeedback Explorer Quick Insert Electrode TruScan Neurofeedback optical cable V3.3L Recording Cap G1 Cable for connection TruScan Neurofeedback 24ch TruScan LT 32 Neurofeedback headbox FlexiCAP electrode ring - rubber TruScan Neurofeedback Acquisition Headbox Safety Ribbon Cable for Cap Connection Wrist Band Electrode Sn(Tin) Set for the application of EEG recording gel Deymed Li-ion Battery Disc Electrode 9mm Sn (Tin) Ear Electrode Sn (Tin) Body Harness TruScan LT 24 Neurofeedback headbox Splitter FlexiCAP TruScan Neurofeedback 32ch TruScan Neurofeedback Adapter Pair of Ear Electrodes Sn (Tin) Disposable blunted needles EEG cap strap

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198