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

    ENERGEX

    K Number: K042686 · Decision Jun 16, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    260

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    Basic Information

    Device Name
    ENERGEX
    K Number
    K042686
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Energex Systems, Inc.
    Date Received
    September 29, 2004
    Decision Date
    June 16, 2005
    Product Code
    NHH
    Advisory Committee
    Physical Medicine
    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
    NHH Device, Discharge, Electrostatic (For Pain Relief)

    Similar 510(k) Clearances

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

    ORTHOSONIX ENERGEX

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    FDA Class 2 ·Physical Medicine
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