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

    ORTHOSONIX ENERGEX

    K Number: K013094 · Decision Dec 14, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    88

    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
    ORTHOSONIX ENERGEX
    K Number
    K013094
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthosonix, Inc.
    Date Received
    September 17, 2001
    Decision Date
    December 14, 2001
    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.

    ENERGEX

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all