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

    WALK-A-CYCLE

    K Number: K820711 · Decision Apr 8, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    337
    Registration Numbers
    337
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    24

    Basic Information

    Device Name
    WALK-A-CYCLE
    K Number
    K820711
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3825
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    WALK-A-CYCLE DIVISION
    Date Received
    March 15, 1982
    Decision Date
    April 8, 1982
    Product Code
    ITJ
    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
    ITJ Walker, Mechanical

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