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

    OMNISOUND THERAPY UNIT

    K Number: K843372 · Decision Sep 18, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    88
    Applicant Total
    10
    Review Days
    21

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    Basic Information

    Device Name
    OMNISOUND THERAPY UNIT
    K Number
    K843372
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5300
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Physio Technology, Inc.
    Date Received
    August 28, 1984
    Decision Date
    September 18, 1984
    Product Code
    IMI
    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
    IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

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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
    K861039 OMNIVAC (VACUUM ELECTRODE SYSTEM)
    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
    K841874 MEGA PULSE THERAPY UNIT
    K841278 OMNISTIM III INTERFERENTIAL THERAPY