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510(k) Data Aggregation

    K Number
    K222136
    Device Name
    Cryo-Thermo Compression Device (FGK002)
    Date Cleared
    2023-03-08

    (232 days)

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

    Suzhou MicroPort RehabTech (Group) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Cryo-Thermo Compression Device combines cold, heat and compression therapies. It is intended to treat post-surgical and acute injuries to reduce edema, swelling and pain for which cold and compression are indicated. It is intended to treat post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated. It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics and athletic training settings.
    Device Description
    Cryo-Thermo Compression Device. Model Number: FGK002. is an AC powered. software-controlled device, designed to be used in rehabilitation facilities, outpatient clinics and athletic training settings and under the direction, prescription, or supervision of a licensed healthcare professional. Cryo-Thermo Compression Device features iceless cold therapy, heat therapy and intermittent pneumatic compression therapy. Cryo-Thermo Compression Device provides various inflatable wraps for thermal treatment (heat or cold) of the elbow, shoulder, ankle, hand-wrist or knee. The wraps are reusable for a single patient and can be cleaned if necessary. Cryo-Thermo Compression Device is controlled by a touch screen interface, allowing the user to manage in the therapy modalities as well as easily adjust treatment temperature, compression level and time settings. Cryo-Thermo Compression Device consists of a main equipment, wraps and accessories. The main equipment includes a control unit, a hose and a power cable. The drainpipe and the ice stick are accessories which can be ordered upon request. It is approximately 17.641bs (8kg) when reservoir is full of coolant. And, it is recommended to use 10% ethanol with 90% distilled water as the coolant.
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