BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P210035 · Supplement: S003 · Decision Mar 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    AccelStim
    PMA Number
    P210035
    Supplement Number
    S003
    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
    March 21, 2025
    Date Received
    September 9, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for an updated "next generation/AccelStim 2.0" version of the AccelStim device to include modifications to the controller user interface, ergonomics, aesthetics, and the integration of Bluetooth data transfer for connectivity with the optional Stim onTrack mobile application. The Stim onTrack mobile application has also been updated to optionally incorporate activity tracker data.

    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