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510(k) Data Aggregation

    K Number
    K231437
    Device Name
    LF900
    Manufacturer
    Daesung Maref Co., Ltd
    Date Cleared
    2023-07-19

    (63 days)

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

    Daesung Maref Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K202395
    Device Name
    SP-1000, SP-2000
    Manufacturer
    DaeSung Maref Co., Ltd
    Date Cleared
    2021-09-01

    (376 days)

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

    DaeSung Maref Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SP-1000/2000 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.
    Device Description
    Operating principal of this device is that the air output from the air motor is delivered to a sleeve composed of four air chambers which are sequentially inflated from the first air chamber to the fourth chamber. SP-1000 can adjust the pressure values of all chambers at once. The SP-2000 can adjust the pressure value for each channel. This device is composed of a power supply, a pump, a control unit, and a wearable unit. The power applied from the power supply is applied to the pump. And user can adjust the time through time control knob, during which time power is supplied to the air pump. When the set time is over, the pump will stop working. Air pump creates air pressure and transmits it to the Synchro motor. The air delivered to the synchro motor distributes the air to each channel of the sleeve. And there is a pressure control valve between the synchro motor, the user can adjust the pressure of each sleeve through the pressure control knob. The sleeve prevents blood from accumulating by repeatedly applying inflation/deflation to the wearing to the type of the sleeve, it can apply to the leg, lower body, and arm.
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    K Number
    K203498
    Device Name
    LX9max
    Manufacturer
    Daesung Maref CO., LTD.
    Date Cleared
    2021-07-02

    (217 days)

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

    Daesung Maref CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A device intended to temporarily relieve minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health.
    Device Description
    This product is an Intermittent Pneumatic Compression system to temporarily relieve minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The operating principle is that the air from the device will be delivered to the sleeve with 4 air chambers and the air pressurizes sequentially the chambers from 1st to 4th.
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    K Number
    K203019
    Device Name
    LF900
    Manufacturer
    DaeSung Maref Co., Ltd
    Date Cleared
    2021-06-22

    (264 days)

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

    DaeSung Maref Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LF900 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
    This product is an Intermittent Pneumatic Compression system to improve the blood circulation of the human body. The operating principle is that the air from the device will be delivered to the sleeve with 4 air chambers and the air pressurizes sequentially the chambers from 1st to 4th.
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    K Number
    K203353
    Device Name
    DVT-PRO
    Manufacturer
    Daesung Maref Co., LTD
    Date Cleared
    2021-04-22

    (160 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Daesung Maref Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DVT-PRO is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-PRO is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis Edema - Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery Leg Ulcers, Venous Stasis / Venous Insufficiency.
    Device Description
    In this device, sleeves continuously inflated/deflated by the air pressure generated by the pump. This pressurization increases blood flow and prevent DVT/PE. Operating principal of this device is that the air output from the air motor is delivered to a sleeve composed of four air chambers are sequentially inflated from the first air chamber to the third chamber through solenoid valve.
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    K Number
    K203417
    Device Name
    DVT-4000S
    Manufacturer
    Daesung Maref CO., LTD.
    Date Cleared
    2021-03-28

    (129 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Daesung Maref CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A device intended to prevent Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) by increasing venous blood flow to a patient who has a risk of DVT/PE.
    Device Description
    A device intended to prevent DVT/PE by increasing venous blood flow to a patient who has a risk of DVT/PE. Operating principal of this device is that the air output from the air motor is delivered to a sleeve composed of four air chambers are sequentially inflated from the first air chamber to the third chamber through solenoid valve.
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    K Number
    K203016
    Device Name
    DVT-2600
    Manufacturer
    Daesung Maref Co., LTD
    Date Cleared
    2020-12-05

    (65 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Daesung Maref Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A device intended to prevent Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) by increasing venous blood flow to a patient who has a risk of DVT/PE.
    Device Description
    A device intended to prevent DVT/PE by increasing venous blood flow to a patient who has a risk of DVT/PE. Operating principal of this device is that the air output from the air motor is delivered to a sleeve composed of four air chambers are sequentially inflated from the first air chamber to the third chamber through solenoid valve.
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    K Number
    K160178
    Device Name
    Lympha-Flow(LF1200)
    Manufacturer
    DaeSung Maref Co., Ltd
    Date Cleared
    2017-01-11

    (350 days)

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

    DaeSung Maref Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lympha-Flow(LF1200) 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
    Lympha-Flow(LF1200) is the pressurization system helping to relieve the symptom of lymphedema and prevent aggravation of symptoms by applying the air pressure to limbs. Lympha-Flow(LF1200) comprises of 12-step sleeves and accelerates the circulation of body fluid by evenly distributing the pressure to limbs.
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    K Number
    K160180
    Device Name
    Intermittent Pneumatic Compression system
    Manufacturer
    DaeSung Maref Co., Ltd
    Date Cleared
    2016-11-03

    (281 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    DaeSung Maref Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DVT-4000 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-4000 is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.
    Device Description
    DVT-4000 device is a specialized intermittent pneumatic compression (IPC) system to prevent DVT (Deep Vein Thrombosis) and PE (Pulmonary Embolism) by improving the venous blood flow in at risk patients. The system consists of the controller, the tubing sets and Non- woven, sleeves. The system offers sequential inflation promoting venous blood movement and metabolism and then has sufficient interval time to refill with blood sufficiently after deflation. The operation of the inflation and deflation is repeated until the stop button is activated. The device may be used with anti-coagulant materials or compression stocking to help prevent DVT and PE under a doctor's consultant.
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    K Number
    K150980
    Device Name
    Venous Assist System
    Manufacturer
    DAESUNG MAREF CO., LTD.
    Date Cleared
    2016-05-12

    (394 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAESUNG MAREF CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DVT-Pro is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-Pro is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.
    Device Description
    DVT-Pro device is a specialized intermittent pneumatic compression (IPC) system to prevent DVT (Deep Vein Thrombosis) and PE (Pulmonary Embolism) by improving the venous blood flow in at risk patients. The basic set of The Venous Assist System(DVT-PRO) consists of the main body, which includes the air pump that generates air pressure and control panel, air hose that transfers air pressure and sleeve (cuff) for calf and foot.
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