BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SOFTWAVE TISSUE REGENERATON TECHNOLOGIES, LLC

    Reg #: 3006066512 · FEI: 3006066512 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    18
    Establishment Types
    2
    Classifications
    3

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    Registration Details

    Registration Name
    SOFTWAVE TISSUE REGENERATON TECHNOLOGIES, LLC
    Registration Number
    3006066512
    FEI Number
    3006066512
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    10000 Avalon Blvd, Suite 720
    City
    Alpharetta
    State
    GA
    ZIP
    30009
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210451

    Owner / Operator

    Firm Name
    TISSUE REGENERATION TECHNOLOGIES, LLC
    Operator Number
    9094965
    Address
    10000 Avalon Blvd, Suite 720
    City
    Alpharetta
    State
    GA
    Postal Code
    30009
    Country
    US
    Correspondent
    John F Warlick

    Products

    Device Name Product Code
    Massager, Therapeutic, Electric ISA
    Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers PZL
    Lithotriptor, Extracorporeal Shock-Wave, Urological LNS

    Proprietary Names

    Viasure Applicator OP 155 SoftWave OrthoGold 100 Applicator OP 155S OW100S UroGold OrthoGold Applicator OE0035 and OE0050 DermaGold DermaGold, OrthoGold OW100S, OrthoGold, DermaGold SoftWave Gold Li SoftWave Gold ChiroGold OrthoGold or DermaGold DERMAGOLD LithoGold

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility