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510(k) Data Aggregation

    K Number
    K992099
    Device Name
    BIO SPA INTELLIGENT
    Manufacturer
    Date Cleared
    2002-01-18

    (942 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    STARBENE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MUSCLE STIMULATION THERAPY DELIVERED BY THE BIO SPA INTELLIGENT DEVICE IS INDICATED FOR THE FOLLOWING USES : - 1- Relaxation of Muscle Spasm - 2- Prevention or retardation of disuse atrophy - 3- Increasing local blood circulation - 4- Muscle re-education - 5- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis, and - 6- Maintaining or increasing range of motion
    Device Description
    Not Found
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    K Number
    K991613
    Device Name
    SW ULTRASOUND, MODELS 331, 311, 333
    Manufacturer
    Date Cleared
    2000-12-08

    (578 days)

    Product Code
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    STARBENE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SW Ultrasound Line is intended for use in applying therapeutic deep heat for selected medical conditions. Ultrasound therapy is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies (21 CFR 890.5300) IS A THERAPEUTICAL ULTRASONIC DIATHERMY DEVICE FOR ION THEFULL LONSE TO APPLY THERAPEUTIC DEEP HEAT FOR SELECTED MEDICAL CONDITIONS.
    Device Description
    The SW Ultrasound Line is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
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