BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    MFE COUCH ERGOMETER

    K Number: K850869 · Decision Jun 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    60
    Applicant Total
    10
    Review Days
    103

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    Basic Information

    Device Name
    MFE COUCH ERGOMETER
    K Number
    K850869
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5360
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Ketronic, Inc.
    Date Received
    March 1, 1985
    Decision Date
    June 12, 1985
    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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    Other Clearances by Ketronic, Inc.

    K Number Device Name
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    K850873 HILO TABLES, TYPE CH-4, CH-8, FW-6, FW-5, FW-2, AL
    K850870 MEDIFETTE ERGOMETER
    K850868 MFE CARDIAC STRESS SYSTEM
    K850872 PHYACTION 300, 360, 370, 390 & 391 ELEC-MUSCLE-STI
    K850871 TREDBAND TYPE I, IT, II & III - TREADMILLS
    K850876 LIGTVOET L80.2 LIGHTFOOT L80.2 POWER WHEELCHAIR
    K850875 ACTION-WHEELS & PLAY WHEELS
    K843288 KETRONIC MEDAX - N