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510(k) Data Aggregation

    K Number
    K191441
    Device Name
    Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)
    Date Cleared
    2021-03-05

    (645 days)

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

    Maxstar Industrial Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Air Relax/ Compressible Limb Sleeve System (Model: AR-1.0) 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. The Air Relax/ Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) simulates kneading and stroking of tissues by using an inflatable garment.
    Device Description
    AR-1.0, AR-2.0is combined with leg, foot, garments. Leg garment has four air chambers operated by STEP3 controller and foot has one air chamber operated by STEP1. STEP3 controls a leg garment compressing sequentially in order of foot, calf and thigh and then injecting fresh air inside a leg garment through holes of garment to prevent from generating sweat by long wear of a garment.
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    K Number
    K173158
    Device Name
    Air Relax
    Date Cleared
    2019-05-30

    (608 days)

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

    Maxstar Industrial Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    UAM-8100, UAM-8100N is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.
    Device Description
    UAM-8100, UAM-8100N is a system to improve the blood circulation of patients and User can use it personally under their doctor's indication and guidance. UAM-8100, UAM-8100N is combined with leg and foot garments. The leg garment has four air chambers operated by a controller. The leg garment is compressed sequentially in order of foot, calf, and thigh, and then fresh air is injected inside the leg garment through holes
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