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510(k) Data Aggregation

    K Number
    K211283
    Device Name
    Compressible Limb and Circulation Therapy System, Model POWER-Q2300
    Date Cleared
    2021-09-14

    (140 days)

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

    Wonjin Mulsan Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    POWER-Q2300 is intended for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER-Q2300 simulates kneading of tissues by using an inflatable garment (cuff).
    Device Description
    POWER-Q2300 is comprised of a main body, a power cord, cuffs, and hoses for connecting the device to the cuffs. The device is AC-powered. There are four cuffs to apply to different body areas, such as leg, arm, hip, and half-leg. The cuffs have 4-chambers. The cuff inflates and deflates sequentially to apply the pressure on the target body areas which are controlled by the main body. Double hose is to connect main body and leg cuff. Single hose is to connect main body and arm cuff (or hip cuff or half-leg cuff). Extension zipper is for bigger leg. Blocked jack is to block an air outlet that will not be used. The colors of the cuffs and extension zipper are available in pink or gray.
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    K Number
    K200660
    Device Name
    Compressible Limb and Circulation Therapy System
    Date Cleared
    2021-03-08

    (361 days)

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

    Wonjin Mulsan Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    POWER RECOVERY is intended for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER RECOVERY simulates kneading and stroking of tissues by using an inflatable garment (cuff).
    Device Description
    Compressible Limb and Circulation Therapy System Model POWER RECOVERY is a powered inflatable tube massager, and comprised of a main body, an AC-DC adapter, cuffs with hose, and a hose adapter and a main hose for connecting the device to the cuffs. The device is powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery. There are three cuffs to apply to different body areas, such as leg, arm, and hip. Leg cuff and arm cuff have 6-chambers and hip cuff has 5-chambers. The cuffs can be inflating and deflating sequentially to apply the pressure on the target body areas which are controlled by the main body. The device simulates kneading and stroking of tissues by using an inflatable garment (cuff) to temporarily relieve minor muscle aches and pains and to temporarily increase blood circulation to the tested areas in people who are in good health.
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    K Number
    K100656
    Device Name
    COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS)
    Date Cleared
    2010-05-26

    (79 days)

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

    WONJIN MULSAN CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    WHF-324 (POWER-Q1000 PLUS) 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
    WHF-314 (POWER Q1000) is Used with four chamber garments for full leg, and period has its own variable duration.pressure, cvcle time and gradient setting. Power unit features visual operation statusand fault indicators.
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    K Number
    K080134
    Device Name
    COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)
    Date Cleared
    2009-01-23

    (371 days)

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

    WONJIN MULSAN CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The WHF-314 (POWER Q1000) device 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, Post immobilization edema, Venous insufficiencies, Lymphedema
    Device Description
    WHF-314 (POWER Q1000) is Used with four chamber garments for full leg, and period has its own variable duration, pressure, cycle time and gradient setting Power unit features visual operation status and fault indicators
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