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Found 7 results
510(k) Data Aggregation
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
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
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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K Number
K150033Device Name
Air Compressible Limb Therapy System
Manufacturer
DAESUNG MAREF CO., LTD.
Date Cleared
2015-04-20
(101 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
LF-400 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
LF400 is the pressurization system helping to relieve the symptom of lymphedema and prevent aggravation of symptoms by applying the air pressure to limbs. LF400 comprises 4-step sleeves which move the body fluids through the limbs by evenly applying pressure to the limbs. The basic set of Air Compression Therapy System consists of the main body, which includes the air pump that generates air pressure and control panel, air hose that transfers air pressure and cutoff sleeve (cuff) for leg and its accessories include overlapping sleeve (cuff) for leg, cutoff sleeve (cuff) for arm, overlapping sleeve (cuff) for arm, cutoff sleeve (cuff) for waist and pants sleeve (cuff). The device consists of 4 parts-PCB, control panel, air pump (AC motor pump) and distributor (solenoid).
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K Number
K112441Device Name
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
Manufacturer
DAESUNG MAREF CO., LTD.
Date Cleared
2012-01-17
(146 days)
Product Code
IRP, CLA
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
MK300L 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
MK300L 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 statusand fault indicators.
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K Number
K112677Device Name
THE VENOUS ASSIST SYSTEM
Manufacturer
DAESUNG MAREF CO., LTD.
Date Cleared
2012-01-13
(121 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-2600 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-2600 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
DVT-2600 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 3 types(Non-woven, Fabric, Oxford) garments. 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.
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K Number
K102320Device Name
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7)
Manufacturer
DAESUNG MAREF CO., LTD.
Date Cleared
2011-03-04
(199 days)
Product Code
IRP, CLA
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
LX7(V7) 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
LX7(V7) 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 statusand fault indicators.
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