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

    SOUTHERN CROSS HI-V4 PULSED HIGH VOLTAGE GALVANIC

    K Number: K900647 · Decision Oct 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    7
    Review Days
    255

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    Basic Information

    Device Name
    SOUTHERN CROSS HI-V4 PULSED HIGH VOLTAGE GALVANIC
    K Number
    K900647
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Nor-Am Patient Care Products, Inc.
    Date Received
    February 9, 1990
    Decision Date
    October 22, 1990
    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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    Other Clearances by Nor-Am Patient Care Products, Inc.

    K Number Device Name
    K844389 ESCOTEK EST 210, HIGH VOLTAGE ELECTRO GALVANIC STI
    K844387 ESCOTEK-EST 221 VACUUM UNIT
    K844388 ESCOTEK EST 220 INTERFERENCE THERAPY UNIT
    K844390 ESCOTEK-EST 204 MULTI STIM
    K844386 ESCOTEK-EST 301A ULTRA-SONIC UNIT
    K844385 ESCOTEK EST TRAC 401