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510(k) Data Aggregation
K Number
K231437Device Name
LF900
Manufacturer
Daesung Maref Co., Ltd
Date Cleared
2023-07-19
(63 days)
Product Code
IRP
Regulation Number
890.5650Why 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
K202395Device Name
SP-1000, SP-2000
Manufacturer
DaeSung Maref Co., Ltd
Date Cleared
2021-09-01
(376 days)
Product Code
IRP
Regulation Number
890.5650Why 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
K203498Device Name
LX9max
Manufacturer
Daesung Maref CO., LTD.
Date Cleared
2021-07-02
(217 days)
Product Code
IRP
Regulation Number
890.5650Why 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
K203019Device Name
LF900
Manufacturer
DaeSung Maref Co., Ltd
Date Cleared
2021-06-22
(264 days)
Product Code
IRP
Regulation Number
890.5650Why 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
K203353Device Name
DVT-PRO
Manufacturer
Daesung Maref Co., LTD
Date Cleared
2021-04-22
(160 days)
Product Code
JOW
Regulation Number
870.5800Why 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
K203417Device Name
DVT-4000S
Manufacturer
Daesung Maref CO., LTD.
Date Cleared
2021-03-28
(129 days)
Product Code
JOW
Regulation Number
870.5800Why 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
K203016Device Name
DVT-2600
Manufacturer
Daesung Maref Co., LTD
Date Cleared
2020-12-05
(65 days)
Product Code
JOW
Regulation Number
870.5800Why 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
K160178Device Name
Lympha-Flow(LF1200)
Manufacturer
DaeSung Maref Co., Ltd
Date Cleared
2017-01-11
(350 days)
Product Code
IRP
Regulation Number
890.5650Why 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
K160180Device Name
Intermittent Pneumatic Compression system
Manufacturer
DaeSung Maref Co., Ltd
Date Cleared
2016-11-03
(281 days)
Product Code
JOW
Regulation Number
870.5800Why 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
K150980Device Name
Venous Assist System
Manufacturer
DAESUNG MAREF CO., LTD.
Date Cleared
2016-05-12
(394 days)
Product Code
JOW
Regulation Number
870.5800Why 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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