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

    BACK MASTER

    K Number: K914394 · Decision Nov 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    159
    Applicant Total
    10
    Review Days
    43

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    Basic Information

    Device Name
    BACK MASTER
    K Number
    K914394
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5380
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Progressive Electrical Therapeutics
    Date Received
    October 1, 1991
    Decision Date
    November 13, 1991
    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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