BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LithoDiamond

    Reg #: 3005655081 · FEI: 3005655081 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HealthTronics, Inc
    Registration Number
    3005655081
    FEI Number
    3005655081
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1990 Steam Way, Suite A 102
    City
    Round Rock
    State
    TX
    ZIP
    78665
    Country
    US

    Regulatory Submissions

    510(k) Number
    K021775

    Owner / Operator

    Firm Name
    HealthTronics, Inc
    Operator Number
    10058145
    Address
    1990 Steam Way, Suite A 102
    City
    Round Rock
    State
    TX
    Postal Code
    78665
    Country
    US
    Correspondent
    David Furr

    Products

    Device Name Product Code
    Lithotriptor, Extracorporeal Shock-Wave, Urological LNS

    Proprietary Names

    LithoDiamond

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198