Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K203052
    Device Name
    Movement and Compressions System (the MAC System)
    Manufacturer
    Recovery Force, LLC
    Date Cleared
    2021-03-21

    (165 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Recovery Force, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Movement and Compressions System is intended to be a portable system, prescribed by healtheare professionals, to treat the following conditions by stimulating blood flow in the legs: - · Aid in the prevention of DVT (deep vein thrombosis) by enhancing blood circulation; and, - · As a prophylaxis for DVT by persons expecting to be stationary for long periods of time. During use, the system also monitors patient orientation and movement. It allows healthcare providers and users to implement individualized patient management plans for DVT prophylaxis and patient mobility protocols by utilizing data accumulated by the patient on the previous day as a benchmark. The data displayed on the device allows providers to monitor the patient's orientation and activity, which can be used to identify risk factors for hospital-acquired events linked to immobility such as: deep vein thrombosis, pressure ulcers, pneumonia, atrophic muscles, and delirium. The device can be used in the home or clinical setting. The device is intended for use in an adult patient population.
    Device Description
    The Movement and Compressions System (The MACTM System) is a prescriptive, portable, rechargeable-battery powered, intermittent compression device designed to stimulate blood flow in the lower limb. The MAC System consists of the MAC Strap, MAC Charging Hub, and MAC Controller. The MAC Strap is a disposable single patient use strap that is wrapped around the patient's calf muscle. The MAC Controller houses a rechargeable battery, DC motor, gyroscope sensor, and microprocessor that is attached to the strap during use. The battery is removed from the controller for charging in the supplied MAC Charging Hub when not in use. Compression is applied to the calf, immediately below the knee, by intermittent application of mechanical force by the device strap. When the strap is contracted, compression is applied to the patient's calf muscle. When the strap is retracted, compression force is released from the patient's calf muscle. Since mechanical force is used to provide intermittent compression, the system does not require a powered air supply, so the risk of aerosolization of potential contaminants or germs is mitigated as there is no blowing air. There are no air connections or pneumatic pumps to clean between patients. The MAC system also monitors and displays patient orientation and movement information. This data is stored in a RFID tag in the MAC Strap. When the MAC Controller is connected to the MAC Strap, and functioning, all DVT prophylaxis compliance data, orientation and movement data is synced between the controller and the strap using Radio Frequency Identification (RFID) communication and stored between them.
    Ask a Question

    Page 1 of 1