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510(k) Data Aggregation

    K Number
    K221043
    Device Name
    Doctor Tecar Plus, Doctor Tecar Smart
    Date Cleared
    2023-02-17

    (315 days)

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

    Mectronic Medicale S.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Doctor Tecar Plus and Doctor Tecar Smart devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation.
    Device Description
    Doctor Tecar Plus and Doctor Tecar Smart are devices for diathermy. This therapy develops an increase in temperature in the area of the body which is treated through the passage of a particular electrical current. Through twin delivering modes, capacitive and resistive, the operator can set a specific treatment. The purpose of the treatment is to raise the temperature inside the tissue at a value maximum to 45 °C. The device is composed by a touch screen and a Multi-Function knob (only Plus model) for managing all the device's functions, a plate, an handpiece for the delivery of radiofrequency energy, software and an on/off button to activate and deactivate the energy emission.
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    K Number
    K183693
    Device Name
    Doctor Tecar
    Date Cleared
    2019-02-22

    (53 days)

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

    Mectronic Medicale S.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Doctor Tecar device 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 Doctor Tecar generates a high frequency sinusoidal current with a monopolar 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 both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in a capacitor resistive monopolar mode. The product consists of a power console on a moveable trolley, LCD monitor, and accessories including capacitive resistive electrodes and multipolar electrodes. The unit can be adjusted to provide various levels of treatment frequency ranging from 460 KHz to 600 KHz.
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