BEUDAMED
    FDA Registration Active 🇺🇸 United States

    THERMOTEK, INC.

    Reg #: 1648700 · FEI: 3000204260 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    9
    Establishment Types
    4
    Classifications
    5

    Registration Details

    Registration Name
    THERMOTEK, INC.
    Registration Number
    1648700
    FEI Number
    3000204260
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1200 LAKESIDE PKWY STE 200
    City
    Flower Mound
    State
    TX
    ZIP
    75028
    Country
    US

    Regulatory Submissions

    510(k) Number
    K103247

    Owner / Operator

    Firm Name
    THERMOTEK, INC.
    Operator Number
    9016830
    Address
    1200 Lakeside Parkway #200, --
    City
    Flowermound
    State
    TX
    Postal Code
    75028
    Country
    US
    Correspondent
    Sara - Lee

    Products

    Device Name Product Code
    Sleeve, Limb, Compressible JOW
    Pack, Hot Or Cold, Water Circulating ILO
    Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat PFW
    Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat IMI
    Scalp Cooling System PMC

    Proprietary Names

    entre` System VascuComp VascuTherm ProThermo ArTek Pro ArTek Sport ThermoComp EchoRx DigniCap Delta Scalp Cooling System

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)