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510(k) Data Aggregation

    K Number
    K243206
    Device Name
    Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)
    Manufacturer
    Sichuan Qianli-beoka Medical Technology Inc.
    Date Cleared
    2025-02-19

    (141 days)

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

    Sichuan Qianli-beoka Medical Technology Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by the use of an inflatable pressure cuff. The devices are to be used by people who are in good health. The devices are powered by an internal IEC 62133-2 compliant lithium-ion battery. The user interface on the Air compression massager is a series of buttons with a small display screen to display the treatment time, pressure level, mode and chamber status. The user interface provides for: Starting and stopping the massage treatment; Adjusting treatment related parameters such as treatment time and pressure level etc.; Selection of the chamber to boost the pressure. In addition to the user interface on the devices, the subject device have Bluetooth capability that allows the use of a Beoka 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. The product is provided non-sterile, and not to be sterilized by the user prior to use. All models in this submission are the same except for the color of controller and button shape.
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