BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application

    K Number: K220454 · Decision Apr 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    410

    Basic Information

    Device Name
    Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
    K Number
    K220454
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5310
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avation Medical, Inc.
    Date Received
    February 17, 2022
    Decision Date
    April 3, 2023
    Product Code
    NAM
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NAM Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NAM), ordered by most recent decision date.

    ZIDA Wearable Neuromodulation System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NURO NEUROMODULATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    URGENT PC STIMULATOR; URGENT PC LEAD SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    URGENT PC NEUROMODULATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all