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

    Flexitouch System

    K Number: K170216 · Decision May 26, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    3
    Review Days
    122

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    Basic Information

    Device Name
    Flexitouch System
    K Number
    K170216
    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. (Dba Tactile Medical)
    Date Received
    January 24, 2017
    Decision Date
    May 26, 2017
    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. (Dba Tactile Medical)

    K Number Device Name
    K203178 Flexitouch Plus System
    K153311 Flexitouch System