BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MODEL 418 SERIES WALKERS

    K Number: K053192 · Decision Dec 5, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    20

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    Basic Information

    Device Name
    MODEL 418 SERIES WALKERS
    K Number
    K053192
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3825
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mjm International Corporation
    Date Received
    November 15, 2005
    Decision Date
    December 5, 2005
    Product Code
    NXE
    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
    NXE Walker, Mechanical, Poly Vinyl Chloride (Pvc)