BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PDI WORKS, LLC

    Reg #: 3010328269 · FEI: 3010328269 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    PDI WORKS, LLC
    Registration Number
    3010328269
    FEI Number
    3010328269
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2150 S LEE HWY
    City
    Cleveland
    State
    TN
    ZIP
    37311
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113037

    Owner / Operator

    Firm Name
    PDI Works, LLC
    Operator Number
    10044465
    Address
    2150 South Lee Hwy
    City
    Cleveland
    State
    TN
    Postal Code
    37311
    Country
    US
    Correspondent
    Thu-Ha T Duncan

    Products

    Device Name Product Code
    Stimulator, Electrical, Transcutaneous, For Arthritis NYN
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Analyzer, Body Composition, Exempt PUH

    Establishment Types

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