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

    NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM

    K Number: K973096 · Decision Jun 12, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    4
    Review Days
    297

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    Basic Information

    Device Name
    NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM
    K Number
    K973096
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neotonus, Inc.
    Date Received
    August 19, 1997
    Decision Date
    June 12, 1998
    Product Code
    KPI
    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
    KPI Stimulator, Electrical, Non-Implantable, For Incontinence

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    Other Clearances by Neotonus, Inc.

    K Number Device Name
    K002889 PNS MAGNETIC STIMULATOR SYSTEM
    K001903 NEOCONTROL PELVIC FLOOR THERAPY SYSTEM
    K973929 NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM