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

    OMNIVAC (VACUUM ELECTRODE SYSTEM)

    K Number: K861039 · Decision Sep 26, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    72
    Applicant Total
    10
    Review Days
    192

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    Basic Information

    Device Name
    OMNIVAC (VACUUM ELECTRODE SYSTEM)
    K Number
    K861039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Physio Technology, Inc.
    Date Received
    March 18, 1986
    Decision Date
    September 26, 1986
    Product Code
    LIH
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LIH Interferential Current Therapy

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    Other Clearances by Physio Technology, Inc.

    K Number Device Name
    K883893 OMNISOUND(TM) 3000
    K874076 MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR
    K850850 AUTOMOVE/OMNISTIM IV-ELECTRICAL MUSCLE STIMULATOR
    K850851 G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S
    K850849 MYOMETER EMG BIOFEEDBACK DEVICE
    K843351 OMNISTIM II COMBIN. THERAPY SYS
    K843372 OMNISOUND THERAPY UNIT
    K841874 MEGA PULSE THERAPY UNIT
    K841278 OMNISTIM III INTERFERENTIAL THERAPY