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

    OMNISTIM III INTERFERENTIAL THERAPY

    K Number: K841278 · Decision Apr 24, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    10
    Review Days
    27

    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
    OMNISTIM III INTERFERENTIAL THERAPY
    K Number
    K841278
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Physio Technology, Inc.
    Date Received
    March 28, 1984
    Decision Date
    April 24, 1984
    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

    Similar 510(k) Clearances

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

    Apollo Quattro (APQ-10M)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    High Tone Power therapy (HiToP) (Model: HiToP PNP)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    StimelMD (SSMD) system

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Compact II

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EVE Synergy (EVE-20M)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TrainFES Advance

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

    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
    K843372 OMNISOUND THERAPY UNIT
    K841874 MEGA PULSE THERAPY UNIT