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

    DIGITAL ELECTRONIC EXERCISER/PULSE MTR.

    K Number: K800072 · Decision Jan 28, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    60
    Applicant Total
    6
    Review Days
    14

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    DIGITAL ELECTRONIC EXERCISER/PULSE MTR.
    K Number
    K800072
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5360
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Sears, Roebuck & Co.
    Date Received
    January 14, 1980
    Decision Date
    January 28, 1980
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ISD), ordered by most recent decision date.

    MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    REAL Immersive System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ActiSpec Activity Monitor

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ERGOSELECT/GE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ACTITRAINER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ERGOSELECT 100 K/P, ERGOSELECT 200 K/P

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Sears, Roebuck & Co.

    K Number Device Name
    K810635 ELECTRODE BLOOD PRESSURE MONITOR
    K800778 DIGITAL ELECTRONIC B.P. MONITOR 2155
    K781701 BLOOD PRESSURE, DIGITAL MODEL #2153
    K780986 DIGITAL BLOOD PRESSURE MONITOR
    K771666 SPHYGMOMANOMETER #1235