BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    entré Model PD08-U

    K Number: K143185 · Decision May 7, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    5
    Review Days
    183

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    Basic Information

    Device Name
    entré Model PD08-U
    K Number
    K143185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tactile Systems Technology, Inc.
    Date Received
    November 5, 2014
    Decision Date
    May 7, 2015
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOW Sleeve, Limb, Compressible

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    Other Clearances by Tactile Systems Technology, Inc.

    K Number Device Name
    K131193 ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM
    K120972 FLEXITOUCH SYSTEM
    K062818 FLEXITOUCH SYSTEM
    K013061 BIOTOUCH MASSAGE THERAPY SYSTEM