BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE

    K Number: K122330 · Decision Dec 7, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    2
    Review Days
    127

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    Basic Information

    Device Name
    FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE
    K Number
    K122330
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arjohuntleigh Polska SP Z.O.O.
    Date Received
    August 2, 2012
    Decision Date
    December 7, 2012
    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 Arjohuntleigh Polska SP Z.O.O.

    K Number Device Name
    K133119 FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS