BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DAVID BACK CLINIC SYSTEM

    K Number: K952163 · Decision Aug 12, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    60
    Applicant Total
    1
    Review Days
    462

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    Basic Information

    Device Name
    DAVID BACK CLINIC SYSTEM
    K Number
    K952163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5360
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kinetic Resources, Inc.
    Date Received
    May 8, 1995
    Decision Date
    August 12, 1996
    Product Code
    ISD
    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
    ISD Exerciser, Measuring

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