Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K131513
    Device Name
    SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY
    Manufacturer
    Date Cleared
    2014-07-11

    (409 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    RITM OKB ZAO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SCENAR Cutaneous Electrode Family with SCENAR TENS devices is indicated for relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain.
    Device Description
    The SCENAR Cutaneous Electrode Family is intended to be used with electrostimulation devices produced by RITM OKB ZAO as external add-on electrode accessories. The SCENAR Cutaneous Electrode Family does not contain any electrical components. Electrodes are made of stainless steel, brass with silver plated, ABS plastic and fluoroplastic placed in ABS plastic case. The electrodes are connected to electrostimulator by wiring through a connector cable.
    Ask a Question

    Ask a specific question about this device

    K Number
    K092117
    Device Name
    SCENAR, MODEL 10
    Manufacturer
    Date Cleared
    2010-05-28

    (318 days)

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

    RITM OKB ZAO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain.
    Device Description
    SCENAR transcutaneous electrostimulators are designed for delivering general noninvasive treatment via human skin areas for relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain. SCENAR devices generate low and medium frequency bipolar electric pulses. The shape of the pulses dynamically varies with changing electrophysiological characteristics of the skin. The device has an upper cover, case with a built-in electrode and a battery cover. All components except for the batteries are located on the printed circuit board inside the device's case. The device's controls and visual indicators are located on the upper side of its case.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1