BEUDAMED
    FDA Registration Active 🇨🇳 China

    DONG GUAN TUTAMEN METALWORKS CO, LTD.

    Reg #: 3011506263 · FEI: 3011506263 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    8
    Establishment Types
    4
    Classifications
    10

    Registration Details

    Registration Name
    DONG GUAN TUTAMEN METALWORKS CO, LTD.
    Registration Number
    3011506263
    FEI Number
    3011506263
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7th Floor, Building 2, Lishi Industrial park,No.26, Keyuan Rd., Tangxia Town
    City
    Dong Guan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K201431

    Owner / Operator

    Firm Name
    Dong Guan Tutamen Metalworks Co, Ltd.
    Operator Number
    10052219
    Address
    No.3 HuangGuoTang Rd., ShaHu,Tangxia Town
    City
    Dong Guan
    State
    Guangdong
    Postal Code
    523725
    Country
    CN

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Stand, Infusion FOX
    Lamp, Infrared, Therapeutic Heating ILY
    Joint, Knee, External Brace ITQ
    Support, Arm IOY
    Joint, Ankle, External Brace ITW
    Unit, Heating, Powered IRQ
    Exerciser, Non-Measuring ION
    Orthosis, Limb Brace IQI
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Crutch IPR

    Proprietary Names

    Progressive ROM Ortho Guards Richmar Hydratherm Spartan TAG Boot IWALK3 - Hands Free Crutch OGYILI TENS/NMES Stimulator iwalk 3 Crutch Assembly

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device