BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇳🇱 Netherlands

    TREDBAND TYPE I, IT, II & III - TREADMILLS

    K Number: K850871 · Decision Jun 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    159
    Applicant Total
    10
    Review Days
    96

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    Basic Information

    Device Name
    TREDBAND TYPE I, IT, II & III - TREADMILLS
    K Number
    K850871
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5380
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Ketronic, Inc.
    Date Received
    March 1, 1985
    Decision Date
    June 5, 1985
    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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