BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Myo Infi U-Cont 60 Hz Home USA

    Reg #: 9680487 · FEI: 1000639819 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    34
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    THOUGHT TECHNOLOGY LTD.
    Registration Number
    9680487
    FEI Number
    1000639819
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5250 FERRIER, SUITE 812
    City
    MONTREAL Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K053434

    Owner / Operator

    Firm Name
    THOUGHT TECHNOLOGY LTD.
    Operator Number
    9009398
    Address
    SUITE #812, 5250 FERRIER
    City
    MONTREAL
    State
    Quebec
    Postal Code
    H4P1L3
    Country
    CA
    Correspondent
    HAL - MYERS

    US Agent

    Business Name
    CIMETRA LLC
    Contact Name
    CINDY BRUNEAU
    Address
    8396 STATE ROUTE 9
    City
    West Chazy
    State
    NY
    ZIP
    12992
    Country
    US
    Email
    [email protected]
    Phone
    518 8467606

    Products

    Device Name Product Code
    Stimulator, Electrical, Non-Implantable, For Incontinence KPI
    Device, Biofeedback HCC
    Stimulator, Muscle, Powered IPF

    Proprietary Names

    Myo Infi U-Cont 60 Hz Home USA SA9807FR - Myotrac Infiniti Power Adaptor - Europe Myotrac3 Upgrade to Infiniti SA9816 - Myotrac Infiniti Clinical Guide and Report Generator SA9807NA - Myotrac Infiniti Power Adaptor - North America Myo Infi U-Cont 60 Hz Clin USA Myotrac 3 Infiniti Continence Myo Infi U-Cont Upgr to Clin T9841- Venus Clinic System 60Hz, English 5150M0031 - Venus Clinic Installation Guide SA7900MV - Venus Biofeedback Software 5150M0021 - Venus Clinic HW User Guide 5150M0011 - Venus Clinic SW User Manual 5031A0011 - Venus Clinic Encoder SA9000 - MyOnyx T9030 - 4-Channel MyOnyx Clinical SA9014 - MyOnyx Rehab Suite T9876 - Venus Clinic System 50Hz, English T9000 - 4-Channel Basic MyOnyx with Mobile App SA9013 - MyOnyx Mobile App T9841US - Venus Clinic System 60Hz, English (USA) Myotrac Infiniti (Saebo) OEM stand-alone,English,60Hz T9915 - Myotrac3 Upgrade to Infiniti T9895EN - Myotrac Infiniti (Saebo) OEM stand-alone,English,60Hz SA9572CAN - Vaginal Stim Sensor SA9800 - Myotrac Infiniti Encoder T9910 - Myotrac 3 Infiniti Continence System T9845US - Myo Infi U-Control 60 Hz Home USA T9815 -Myo Infi U-Control Upgrade to Clinical System SA7977 - Continence Suite Software SA9571CAN - Anal Stim Probe T9900 - MYOTRAC INFINITI SYSTEM T9840US - Myo Infi U-Control 60 Hz Clinical USA MYOTRAC INFINITI SYSTEM

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device