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510(k) Data Aggregation

    K Number
    K023231
    Device Name
    ELFCARE DEVICE, MODELS 314A THROUGH 314G
    Manufacturer
    MEDISEB LTD.
    Date Cleared
    2003-04-04

    (189 days)

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

    MEDISEB LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Microcurrent and IFC (Premodulated Interferential) electrical stimulation using models 314A, 314B, 314C, 314F and 314G: - Symptomatic relief and management of chronic intractable pain - Adjunctive treatment in the management of post-surgical and post-traumatic pain. For VMS Burst, Russian and Biphasic Symmetrical Pulses electrical stimulation using models 314F and 314G: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Maintaining or increasing range of motion - Prevention of venous thrombosis of the calf muscles immediately after surgery For Hot/Cold therapy using models: 314A, 314B, 314C, 314D, 314E: - Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions. - Temporary relief of minor aches and pains and muscle spasms
    Device Description
    The ELFcare™ device is a lightweight hand held battery operated unit which employs a combination application of previously well known electrical and temperature treatment modalities for pain relief and rehabilitation. The system is based on a combination of thermal transfer and conventional transcutaneous electrical stimulation therapy. The ELFcare™ device makes use of an electronically controlled thermoelectric electrode unit that can be operated in cooling or heating modes. The thermoelectric electrode unit is controlled by the hand-held control unit. Cooling: In the cooling mode, the thermoelectric electrode unit produces continuous and accurately controlled cold therapy to the treated area. Heating: When operated in heating mode, well-controlled heat therapy is introduced to the treated area. Electrotherapy: The unit incorporates a 4-head electrode for localized electrotherapy. Electrical and temperature calibrated modalities are applied in pre-programmed sequences and combinations The ELFcare™ device combines electrical and temperature calibrated modalities by means of an electronically controlled thermoelectrode, as described above. The thermoelectrode is placed on the affected area. The thermoelectrode unit is connected to the ELFcare" Control Unit. The treatment programs and treatment parameters are controlled and operated via the ELFcare™ Control Unit.
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