BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Wireless Tens Unit

    Reg #: 3011191255 · FEI: 3011191255 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    VIVE Health LLC
    Registration Number
    3011191255
    FEI Number
    3011191255
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8955 Fontana Del Sol Way
    City
    Naples
    State
    FL
    ZIP
    34109
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121719

    Owner / Operator

    Firm Name
    VIVE Health LLC
    Operator Number
    10047487
    Address
    8955 Fontana Del Sol Way
    City
    Naples
    State
    FL
    Postal Code
    34109
    Country
    US
    Correspondent
    Joseph Fleming

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH

    Proprietary Names

    Wireless Tens Unit RHB1006 Muscle Massager TENS Unit 8 mode

    Establishment Types

    Repack or Relabel Medical Device