BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    SA9020 - MyOnyx

    Reg #: 9680487 · FEI: 1000639819 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    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
    K201014

    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
    Device, Biofeedback HCC
    Stimulator, Electrical, Non-Implantable, For Incontinence KPI

    Proprietary Names

    SA9020 - MyOnyx SA9005 - Vaginal Pressure Probe SA9003 - Pressure Sensor SA9030 - MyOnyx Mobile App T3425 - Electrodes 100 Uni-Gel™ Single

    Establishment Types

    Manufacture Medical Device