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510(k) Data Aggregation

    K Number
    K080902
    Device Name
    FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058
    Date Cleared
    2008-06-13

    (72 days)

    Product Code
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    LORENZ BIOTECH S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Lorenz Biotech S.p.A. FREMS™ SSC Disposable (Foam and Non-Woven) Electrodes are accessories to the Lorenz Biotech Aptiva™ and are intended to be used for electrical stimulation. They are non-sterile and for single patient use only.
    Device Description
    The Lorenz Biotech S.p.A. FREMS™ SSC Disposable (Foam and Non-Woven) Electrodes are accessories for Lorenz Biotech Aptiva™. The silver/silver chloride conductors are covered with Apti-Gel, a medical hydrogel coupling agent. The FREMS™ SSC Disposable Electrodes are provided with either foam or non-woven backing in sealed pouches of 30 electrodes.
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    K Number
    K061828
    Device Name
    LORENZ BIOTECH APTIVA, VERSION 2.13
    Date Cleared
    2007-08-24

    (422 days)

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

    LORENZ BIOTECH S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Aptiva™ v2.13U is a multifunctional transcutaneous electrical nerve stimulator (TENS) equipped with a surface electromyography and electroneurography. Aptiva™ is indicated for symptomatic relief and management of chronic pain, intractable pain and/or as an adjunctive treatment for the management of post-traumatic pain. The dynamic surface electromyography and electroneurography system is used for biofeedback, relaxation training, and muscle re-education as well as monitoring and display of bioelectric signals produced by muscles, stimulate peripheral nerves, and monitor and display the electrical activity produced by nerves.
    Device Description
    The Aptiva™ v2.13U consists of a console on a mobile floor stand, power cord, battery charger, patient remote control, cables, and Manuals (User and Application). The Aptiva™ v2.13U is provided in four functional models (Ballet, Flamenco, Hip-Hop, and Jazz). EMG features are provided in the Ballet and Hip Hop models. One version of the Ballet model (Option Etoile) includes electroneurography (ENG) functions and a printer. Aptiva™ v2.13U uses commercially available electrodes. Models designated "Light" versions do not include the full treatment databases.
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