BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    LYMPHA PRESS PLUS DEVICE

    K Number: K013331 · Decision Nov 30, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    5
    Review Days
    56

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    Basic Information

    Device Name
    LYMPHA PRESS PLUS DEVICE
    K Number
    K013331
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mego Afek
    Date Received
    October 5, 2001
    Decision Date
    November 30, 2001
    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 Mego Afek

    K Number Device Name
    K230385 Ballancer Platinum (1222)
    K072372 PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE
    K060220 PBS MODEL 701A COMPRESSION THERAPY DEVICE
    K810338 LYMPHA PRESS