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510(k) Data Aggregation

    K Number
    K153311
    Device Name
    Flexitouch System
    Manufacturer
    TACTILE SYSTEMS TECHNOLOGY INC (DBA TACTILE MEDICAL)
    Date Cleared
    2016-09-14

    (302 days)

    Product Code
    PPS, JOW
    Regulation Number
    870.5800
    Why did this record match?
    Product Code :

    PPS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexitouch® system and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as: - Lymphedema - Primary lymphedema - · Post mastectomy edema - · Edema following trauma and sports injuries - · Post immobilization edema - · Venous insufficiencies - · Reducing wound healing time · Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers 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® system consists of two main components: a garment set and a pneumatic sequential controller. The garments are wrapped around an affected region so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide for low-level compression therapy. Up to four (4) tubing harness assemblies containing eight (8) discrete individual air passage tubes connect individual garment chambers with the controller.
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