Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K091993
    Device Name
    RAPID PROGRAMMER, VERSION 3.3.0
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC. (ANS INC.)
    Date Cleared
    2009-07-31

    (29 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED NEUROMODULATION SYSTEMS, INC. (ANS INC.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Rapid Programmer is intended to assist clinicians in determining the optimum performance while automatically logging procedures data. Rapid Programmer also allows the clinician to optimize performance by leading the patient through a series of device parameter combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.
    Device Description
    The Rapid Programmer is intended to assist clinicians in determining the optimum performance while automatically logging procedures data. Rapid Programmer also allows the clinician to optimize performance by leading the patient through a series of device parameter combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.
    Ask a Question

    Page 1 of 1