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510(k) Data Aggregation

    K Number
    K211207
    Device Name
    Diacare 7000
    Date Cleared
    2022-06-06

    (410 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Globus Sport and Health Technologies LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Diacare 7000 is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
    Device Description
    The Diacare 7000 is a diathermy device that generates a high frequency sinusoidal current with a monopolar and bipolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a hand-held electrode is manipulated by a therapist. When the electrode is in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in capacitive and resistive monopolar modes. The Diacare 7000 consists of a power console on LCD monitor, and accessories including capacitive and resistive bipolar and monopolar electrodes. The unit can be adjusted to provide various levels of treatment from 400 KHz to 1.2 MHz.
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