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510(k) Data Aggregation

    K Number
    K080950
    Device Name
    STIWELL MED4
    Manufacturer
    OTTO BOCK, AUSTRIA GMBH
    Date Cleared
    2009-04-02

    (364 days)

    Product Code
    IPF, GZI, GZJ, HCC, KPI
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    OTTO BOCK, AUSTRIA GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STIWELL med4 is a neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. As a powered muscle stimulator the STIWELL med4 is indicated for the following conditions: - Relaxation of muscle spasm - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion As a transcutaneous electrical nerve stimulator for pain relief the STIWELL med4 is indicated for the following conditions: - Symptomatic relief and management of chronic (long-term), intractable pain - Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain As a biofeedback device the STIWELL med4 is indicated for the following conditions: - Biofeedback, relaxation and muscle re-education purposes As an external functional neuromuscular stimulator the STIWELL med4 is indicated for the following conditions: - Helps to relearn voluntary motor functions of the extremities As a nonimplanted electrical continence device the STIWELL med4 is indicated for the following conditions: - Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles - Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles
    Device Description
    The STIWELL med4 is powered by rechargeable batteries. It has four stimulation channels and two EMG measurement channels. The STIWELL med4 is intended for stationary use in a hospital as well as home use by the patient. The physician/therapist has the flexibility to adjust the programs and monitors the progress of the therapy. Statistics regarding the completed treatments can be retrieved from the STIWELL med4 and from the PC.
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