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

    JACE MODEL H440 HAND CPM DEVICE

    K Number: K931016 · Decision Jun 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    11
    Applicant Total
    6
    Review Days
    481

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    Basic Information

    Device Name
    JACE MODEL H440 HAND CPM DEVICE
    K Number
    K931016
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5410
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jace Systems, Inc.
    Date Received
    February 26, 1993
    Decision Date
    June 22, 1994
    Product Code
    JFA
    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
    JFA Exerciser, Finger, Powered

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    Other Clearances by Jace Systems, Inc.

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