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

    RECOVERY PUMP 737R

    K Number: K140519 · Decision Jun 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    17
    Review Days
    108

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    Basic Information

    Device Name
    RECOVERY PUMP 737R
    K Number
    K140519
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mego Afek AC , Ltd.
    Date Received
    February 28, 2014
    Decision Date
    June 16, 2014
    Product Code
    IRP
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IRP Massager, Powered Inflatable Tube

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    Other Clearances by Mego Afek AC , Ltd.

    K Number Device Name
    K214053 Amputee Garment for use with Lympha Press Optimal Plus
    K190493 Recovery Pump, 737R (RPX)
    K190015 Ballancer Gold, 1212
    K182003 Lympha Press Optimal Plus
    K172277 Phlebo Press DVT Model
    K170658 Lympha Press Optimal Plus
    K163280 RP Lite 760R
    K150269 Ballancer 505 System, Model 1201-AC
    K142772 Phlebo Press DVT 603
    K140642 PCD 737A
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