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

    ANKLE/FOOT EXTERNAL

    K Number: K820505 · Decision Mar 8, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    11

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    Basic Information

    Device Name
    ANKLE/FOOT EXTERNAL
    K Number
    K820505
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3420
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Mauch Laboratories, Inc.
    Date Received
    February 25, 1982
    Decision Date
    March 8, 1982
    Product Code
    ISH
    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
    ISH Component, External, Limb, Ankle/Foot

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