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510(k) Data Aggregation

    K Number
    K110390
    Device Name
    ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR
    Date Cleared
    2011-07-29

    (168 days)

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

    HANDELSHAUS DITTMAN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ETG 255 Combo Stimulator, For TENS mode Symptomatic relief of chronic intractable pain, relief of acute post-surgical and posttraumatic pain. For EMS mode 1. Relaxation of muscle spasm. 2. Increase of local blood flow circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion. 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis TEN 260 Stimulator Symptomatic relief of chronic intractable pain, relief of acute post-surgical and posttraumatic pain.
    Device Description
    ETG 255 Combo Stimulator, TEN 260 Combo Stimulator are non-invasive devices. The devices contain the following main parts: TENS stimulation unit, Support Belt, electrode, and snap cable. The electrode is permanently sewn up in the support belt. Each belt is flexible, and is available in range of sizes to ensure good patient contact. A male snap connector is placed within the electrode and is connected via the female snap connector to a short lead wire. The lead wire has a female pin connection at the distal end which accepts the lead wire connection from the stimulator. The device can be worn on the low back part of user so as to place the electrode on the treatment location of low back.
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