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

    MARK IV HAND, THUMB AND WRIST (CPM) UNIT

    K Number: K894907 · Decision Oct 6, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    159
    Applicant Total
    2
    Review Days
    66

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    Basic Information

    Device Name
    MARK IV HAND, THUMB AND WRIST (CPM) UNIT
    K Number
    K894907
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5380
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Innovative Medical Engineering, Inc.
    Date Received
    August 1, 1989
    Decision Date
    October 6, 1989
    Product Code
    BXB
    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
    BXB Exerciser, Powered

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