BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P850022 · Supplement: S012 · Decision Jul 26, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    ORTHOPAK BONE GROWTH STIMULATOR
    PMA Number
    P850022
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    LOF
    Generic Name
    Stimulator, bone growth, non-invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 26, 1999
    Date Received
    July 9, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for addition of a 3x5-inch package insert (to be used as a daily patient reminder of the key elements of OrthoPak unit maintenance) into the case of every shipped OrthoPak(R) unit. Each card contains the following information: Bioelectron, Inc., 800-524-0677 Call this number for batteries, electrodes, questions or billing inquiries. 1) Change battery every morning. 2) Change electrodes every 3-7 days or when they will not stick to your skin. Make sure yoru skin is clean and dry before applying new electrodes.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOF Stimulator, Bone Growth, Non-Invasive