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510(k) Data Aggregation

    K Number
    K141360
    Device Name
    TRIPLEPLAY PRO
    Manufacturer
    WILDCAT MEDICAL, INC.
    Date Cleared
    2014-06-12

    (20 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

    TriplePlay Pro (supplied with a pair of model TP-3333, TP-3636, or TP-3434 "cuffs") is indicated for being an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremeties (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:
    • As a prophylaxis for DVT by persons expecting to be stationary for long periods of time .
    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a medical device called "TriplePlay Pro," a compressible limb sleeve system. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls of the FDA.

    Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval, not a technical report detailing performance studies.

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