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510(k) Data Aggregation

    K Number
    K242140
    Device Name
    Air Compression Leg Massager (K-705)
    Manufacturer
    Jiale Health Technology Shenzhen Co., Ltd.
    Date Cleared
    2025-03-17

    (238 days)

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

    Jiale Health Technology Shenzhen Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.
    Device Description
    Air Compression Leg Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading of tissue with the hards by use of inflatable presure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. Air Compression Leg Massager supplied clean and non-sterile, utilizes the pneumatically controlled by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of Controller. Function buttons and light emitting diode (LED) indicators on the user interface. There is a charging port at the bottom of Controller for connecting the alternating current (AC) adapter plug. Each leg wap has an air hose for connection to Controller, and both encase a 2-chamber air bladder inside. It can be wrapped and massaged separately by the two chambers. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance. Air Compression Leg Massager is also capable of providing the warming and vibration, these are included for an improved user experience.
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