BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FKA Distributing Co., LLC

    Reg #: 3016452327 · FEI: 3016452327 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    13

    Registration Details

    Registration Name
    FKA Distributing Co., LLC
    Registration Number
    3016452327
    FEI Number
    3016452327
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    12215 Holly St., --
    City
    Riverside
    State
    CA
    ZIP
    92509
    Country
    US

    Regulatory Submissions

    510(k) Number
    K093831

    Owner / Operator

    Firm Name
    FKA Brands
    Operator Number
    1832894
    Address
    3000 N Pontiac Trail, --
    City
    Commerce Twp
    State
    MI
    Postal Code
    48390
    Country
    US
    Correspondent
    Laura - Foos

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Continuous Measurement Thermometer FLL
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Pack, Hot Or Cold, Reusable IME
    Pad, Heating, Powered IRT
    Massager, Powered Inflatable Tube IRP
    Cold Pack And Vibrating Massager PHW
    Stethoscope, Manual LDE
    Blood Pressure Cuff DXQ
    Oximeter, Infrared, Sporting, Aviation OCH
    Massager, Therapeutic, Electric ISA
    Lamp, Infrared, Therapeutic Heating ILY

    Proprietary Names

    HoMedics Homedics ObusForme HoMedics Bubble Bliss Elite Footbath

    Establishment Types

    Repack or Relabel Medical Device