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510(k) Data Aggregation

    K Number
    K070888
    Device Name
    COMBI 8 MAX
    Date Cleared
    2008-07-03

    (461 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    CEC ELECTRONICA S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Depending on device model, and the specific waveform applied - COMBI pulse generators are indicated for the following uses: COMBI 4/8 DIGITAL, COMBI TREND 4/8 - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy . - . Increasing local blood circulation - Muscle re-education . - . Immediate post-surgical stimulation of calf muscles to prevent venous - thrombosis . - Maintaining or increasing range of motion. . COMBI 4/8 MAX - . Relaxation of muscle spasms - Prevention or retardation of disuse atrophy . - . Increasing local blood circulation - . Muscle re-education - . Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion. . For TENS waveform: - Relief of chronic, intractable pain . - Adjunctive treatment of post surgical or post traumatic acute pain .
    Device Description
    The COMBI family by CEC, is a line of multi-wave pulse generators, intended for medical purposes. The COMBI generators are capable of producing different wave types, such as: three Russian currents (1:1, 2:1, 4:1), symmetric TENS, and symmetric in burst mode: asymmetric TENS, and asymmetric in burst mode; bipolar interferential; three types of impulses, rectangular, triangular, exp + direct current. The devices deliver the predetermined electrical pulses through skin contact adhesive clectrodes, connected to up to four or eight independent body channels, depending on the specific model. (The prefixes 4 and 8 designate the number of channels, respectively). Three different configurations of Multiwave Generator devices comprise the COMBI product line: - 1. COMBI Digital - 2. COMBI Trend - 3. COMBI Max
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