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

    CES ULTRA

    K Number: K062284 · Decision Apr 5, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    241

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CES ULTRA
    K Number
    K062284
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5800
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neuro-Fitness, LLC
    Date Received
    August 7, 2006
    Decision Date
    April 5, 2007
    Product Code
    QJQ
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

    Similar 510(k) Clearances

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

    Genesis Sleep

    FDA 510(k)
    FDA Class 2 ·Neurology

    Modius Stress

    FDA 510(k)
    FDA Class 2 ·Neurology

    Modius Sleep

    FDA 510(k)
    FDA Class 2 ·Neurology

    Cervella

    FDA 510(k)
    FDA Class 2 ·Neurology

    CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C

    FDA 510(k)
    FDA Class 2 ·Neurology

    ELEXOMA MEDIC

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all