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510(k) Data Aggregation

    K Number
    K222201
    Device Name
    Biological Feedback and Stimulation System
    Date Cleared
    2022-10-21

    (88 days)

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

    Medlander Medical Technology Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    As a powered muscle stimulator the Biological Feedback and Stimulation System is indicated for thefollowing 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 biofeedback device the Biological Feedback and Stimulation Systemis indicated for thefollowing conditions: - Biofeedback, relaxationand muscle re-education purposes As a nonimplanted electrical continence device the Biological Feedback and Stimulation Systemisindicated 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 detrusor 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
    This Biological Feedback and Stimulation System is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
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