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510(k) Data Aggregation

    K Number
    K242754
    Device Name
    ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)
    Manufacturer
    ZAMAR Medical d.o.o.
    Date Cleared
    2025-05-05

    (235 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZAMAR Medical d.o.o.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Heat Exchange Equipment for Cryotherapy and Thermotherapy provides a combination of cold, heat, contrast, and compression therapies. It is intended to treat post-surgical and trauma injuries to reduce edema, swelling and pain, for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions, for which localized thermal therapy (hot or cold or contrast) are indicated. The equipment is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, and athletic training settings.
    Device Description
    The Heat Exchange Equipment for Cryotherapy and Thermotherapy (Z-ONE, ZT Cube and ZT Clinic) are AC-powered, software-controlled multi-modality devices, designed to impart localized heat exchange and compression therapies. The devices have been developed with the possibility of choosing between different programs: cold therapy, heat therapy and contrast therapy (alternating hot and cold). Moreover, they also possess an intermittent pneumatic compression activity, which is the effect of an alternance of compression and decompression. The compression activity is available in four different levels: minimum (15 mmHg), low-medium (40 mmHg), medium (60 mmHg) and maximum (80 mmHg). It is also possible for the professional user to select the duration of the pulsed compression. With heat treatment, only a low compression level, i.e. 15 mmHg can be selected. The device allows for a maximum treatment time of 30 minutes for heat therapy, 90 minutes for cold therapy, and 90 minutes for contrast therapy. The devices are designed to be compatible with a series of Thermal Wraps, that are available for different parts of the body: full leg, shoulder, thigh, knee, calf, elbow, wrist, ankle and hip. The devices are designed to be used in rehabilitation facilities, outpatient clinics, and athletic training settings, by, or on the order of, licensed health care professionals. The Heat Exchange Equipment for Cryotherapy and Thermotherapy is available in 3 different models: - **Z-ONE:** portable unit with a comfortable handle for moving. This model is developed to deliver only cold therapy, with a temperature range between 41°F and 59°F (5°C - 15°C) and it allows the connection of up to two wraps at the same time and therefore the possibility to treat more patients using the same program simultaneously. - **ZT Cube:** portable unit with a comfortable handle for moving. This model allows the delivery of cold therapy, heat therapy and contrast therapy (alternating hot and cold), with a temperature range of 34°F as minimum and 104°F as maximum (1°C - 40°C). Up to two wraps can be connected at the same time. - **ZT Clinic:** unit designed and built for the complex needs of clinics and hospitals, as it can suit up to 4 thermal wraps simultaneously. This model can be used to deliver cold therapy, heat therapy and contrast therapy, alternating hot and cold. Temperature range is 34°F as minimum and 113°F as maximum (1°C - 45°C). The devices are controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature and compression settings.
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