BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Belifu TENS001; Letaaka, LLY070; TENS & PMS, Model SM9079, SM9126, SM9126N, SM9186, SM9196

    Reg #: 3018940143 · FEI: 3018940143 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OXILINE LLC
    Registration Number
    3018940143
    FEI Number
    3018940143
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    140 NW 37th ST
    City
    Miami
    State
    FL
    ZIP
    33127
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201354

    Owner / Operator

    Firm Name
    OXILINE LLC
    Operator Number
    10081725
    Address
    140 NW 37th ST
    City
    Miami
    State
    FL
    Postal Code
    33127
    Country
    US
    Correspondent
    Juan Parra

    Products

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

    Proprietary Names

    Belifu TENS001; Letaaka, LLY070; TENS & PMS, Model SM9079, SM9126, SM9126N, SM9186, SM9196

    Establishment Types

    Repack or Relabel Medical Device