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510(k) Data Aggregation

    K Number
    K241446
    Device Name
    Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)
    Date Cleared
    2024-10-08

    (139 days)

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

    Sichuan QianIi-beoka Medical TechnoIogy lnc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Air Compression Massager is an air pressure massager intended to temporarily relieve minor muscle aches and or pains, and to temporarily increase circulation to the treated areas.
    Device Description
    The Air Compression Massager is a medical device that utilizes the principle of air pressure to provide massage to the legs by inflating and deflating. It aims to provide temporary relief for minor muscle aches or pains while temporarily increasing circulation in treated areas. It consists of a sleeve, a main unit and a battery. It mimics manual kneading and stroking of tissues through the use of an inflatable pressure sleeve. The sleeve features 5 chambers designed for different body areas including the foot/ankle, calf, knee, lower quad and upper quad. Controlled by the main unit, it can be sequentially inflated and deflated to apply circulating pressure on targeted body areas. The main component materials of the sleeve are Nylon cloth, thermoplastic polyurethane (TPU). It is available in four sizes: XL (Extra large), L (large), M (medium) and S (small). We offer four models of main unit, ACM-A1, ACM-A2, ACM-A3 and ACM-A4.The main unit is made of polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS). It is the integrated control center that is responsible for starting and stopping treatments, regulating pressure, and mode selection to ensure a precise and safe treatment process. The user interface is a series of buttons showing battery level, pressure level, mode adjustment. The user interface provides for: Starting and stopping the massage treatment; Adjusting intensity (pressure) of the treatment; Select the treatment mode. The air compression massager is charged using® an external compliant power supply as well as powered by an internal IEC 62133-2 compliant lithium-ion battery. All four models of the Air Compression Massager are available with 800mAh, 1000mAh and 2000mAh batteries. In addition, the devices have Bluetooth capability that allows the use of a Mobile app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience.
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