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

    WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000

    K Number: K101035 · Decision Oct 29, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    341
    Applicant Total
    2
    Review Days
    198

    Basic Information

    Device Name
    WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000
    K Number
    K101035
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    WMI ENTERPRISES LLC
    Date Received
    April 14, 2010
    Decision Date
    October 29, 2010
    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 WMI ENTERPRISES LLC

    K Number Device Name
    K100969 WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N