BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Therm-X

    Reg #: 3014834638 · FEI: 3014834638 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ZENITH TECHNICAL INNOVATIONS, LLC
    Registration Number
    3014834638
    FEI Number
    3014834638
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1396 SAINT PAUL AVE
    City
    Gurnee
    State
    IL
    ZIP
    60031
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193550

    Owner / Operator

    Firm Name
    Zenith Technical Innovations, LLC.
    Operator Number
    10058299
    Address
    1396 Saint Paul Ave
    City
    Gurnee
    State
    IL
    Postal Code
    60031
    Country
    US
    Correspondent
    Rebecca Schild

    Products

    Device Name Product Code
    Sleeve, Limb, Compressible JOW
    Pack, Hot Or Cold, Water Circulating ILO
    Massager, Powered Inflatable Tube IRP

    Proprietary Names

    Therm-X

    Establishment Types

    Manufacture Medical Device