BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AVAZZIA, INC.

    Reg #: 3004839404 · FEI: 3004839404 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    16
    Establishment Types
    3
    Classifications
    10

    Registration Details

    Registration Name
    AVAZZIA, INC.
    Registration Number
    3004839404
    FEI Number
    3004839404
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    13140 Coit Rd Ste 515
    City
    DALLAS
    State
    TX
    ZIP
    75240
    Country
    US

    Regulatory Submissions

    510(k) Number
    K053007

    Owner / Operator

    Firm Name
    AVAZZIA, INC.
    Operator Number
    9067759
    Address
    13140 COIT ROAD, STE. 515, --
    City
    Dallas
    State
    TX
    Postal Code
    75240
    Country
    US
    Correspondent
    R - Harman

    Products

    Device Name Product Code
    Stimulator, Electrical, Non-Implantable, For Incontinence KPI
    Massager, Therapeutic, Electric ISA
    Device, Biofeedback HCC
    Cable, Electrode IKD
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Electrode, Cutaneous GXY
    Binder, Medical, Therapeutic MDR
    Light Based Over The Counter Wrinkle Reduction OHS
    Stimulator, Transcutaneous Electrical, Aesthetic Purposes NFO

    Proprietary Names

    Pelvic MS and Pelvic Probes BEST-PRO1 Avazzia Lead Wire Avazzia Blue Med-Sport Med-Best Conductive wrap, conductive garment Biofeedback Microcurrent BEST-RSI AvazziaLife Best-Pro 1, Biomodulator chest electrodes Conductive Clip Flexible Electrode Electrode Pads Pro-Sport Ultra Pro-Sport III

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198