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510(k) Data Aggregation

    K Number
    K251446
    Device Name
    PlasmaFlow X Compression Sleeve Device (XPF0001)
    Manufacturer
    ManaMed, LLC
    Date Cleared
    2025-09-17

    (131 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PlasmaFlow X, Model XPF0001, is intended to be an easy-to-use portable system, prescribed by a physician, for use in the home or in a clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to:

    • Aid in the prevention of DVT
    • Enhance blood circulation
    • Diminish post-operative pain and swelling
    • Reduce wound healing time
    • Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.

    The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

    Device Description

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