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

    ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA

    K Number: K933063 · Decision Jan 27, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    32
    Applicant Total
    6
    Review Days
    219

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    Basic Information

    Device Name
    ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA
    K Number
    K933063
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.1500
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Isotechnologies, Inc.
    Date Received
    June 22, 1993
    Decision Date
    January 27, 1994
    Product Code
    KQX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KQX Goniometer, Ac-Powered

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    Other Clearances by Isotechnologies, Inc.

    K Number Device Name
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    K844060 ISOSTATION ANKLE/SUBTALAR MACHINE A-100
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