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

    MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT

    K Number: K871421 · Decision Jan 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    17
    Review Days
    288

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    Basic Information

    Device Name
    MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT
    K Number
    K871421
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Futuremed Div. of Future Impex Corp.
    Date Received
    April 9, 1987
    Decision Date
    January 22, 1988
    Product Code
    IPF
    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
    IPF Stimulator, Muscle, Powered

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