BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P850007 · Supplement: S025 · Decision May 31, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    PHYSIO-STIM BONE GROWTH STIMULATOR
    PMA Number
    P850007
    Supplement Number
    S025
    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
    May 31, 2000
    Date Received
    March 13, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE PHYSIO-STIM, MODEL 7215 AS FOLLOWS: 1. COMBINE THE TRANSDUCER AND CONTROL UNITS INTO A SINGLE UNIT; 2. POWER THE DEVICE WITH ONE 9-VOLT DISPOSABLE BATTERY RATHER THAN A MULTIPLE CELL NI-CAD BATTERY PACK WITH CHARGER UNIT; 3. BASED ON THE ABOVE CHANGES, REDUCE THE WEIGHT AND OVERALL DIMENSIONS OF THE DEVICE; 4. INDICATE THE OPERATING STATUS OF THE DEVICE WITH THREE LED SIGNAL LIGHTS RATHER THAN AN LCD READOUT; AND 5. CONTROL POWER TO THE DEVICE WITH AN ON/OFF BUTTON RATHER

    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