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510(k) Data Aggregation

    K Number
    K203178
    Device Name
    Flexitouch Plus System
    Manufacturer
    Tactile Systems Technology, Inc. (DBA Tactile Medical)
    Date Cleared
    2020-12-20

    (55 days)

    Product Code
    JOW, PPS
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tactile Systems Technology, Inc. (DBA Tactile Medical)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexitouch Plus Systems and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as - Lymphedema - Primary lymphedema - Post mastectomy edema - Edema following trauma and sports injuries - Post immobilization edema - Venous insufficiency - Reducing wound healing time - Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers - Lipedema - Phlebolymphedema The Flexitouch System and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema .
    Device Description
    The Flexitouch Plus System is an advanced pneumatic compression device clinically proven to stimulate the lymphatic system. The device helps direct and move excess fluid from an impaired lymphatic region to healthy regions, where fluid can be absorbed and processed naturally by your body. Flexitouch Plus garment chambers inflate sequentially with each chamber inflating before the adjacent distal chamber fully deflates. This creates a dynamic wave of therapy that directs fluid into the lymphatic capillaries while maintaining distal pressure to prevent distal backflow.
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