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510(k) Data Aggregation
K Number
K190423Device Name
Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System
Manufacturer
Devon Medical Products (Jiangsu) Ltd
Date Cleared
2019-03-19
(25 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Devon Medical Products (Jiangsu) Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Devon24D deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).
This device can be used in the home or clinical settings to:
- Aid in the prevention of DVT
- Enhance blood circulation
- Diminish post-operative pain and swelling
- Reduce wound healing time
- Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs
- As a prophylaxis for DVT by persons expecting to be stationary for long periods of time
Device Description
Not Found
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K Number
K182578Device Name
Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device
Manufacturer
Devon Medical Products (Jiangsu) Ltd
Date Cleared
2019-02-21
(155 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Devon Medical Products (Jiangsu) Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Devon 62 DVT Prevention Therapy Device is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, obstetric conditions and treatments.
Device Description
The Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life-threatening condition. The Devon 62 DVT Prevention Therapy Device, with a pair of extension tubing, is for use with Cirona DVT calf-thigh and foot garments (sleeves). The device alternatively inflates the two garments and mimic the natural walking pace to enhance circulation. The compression supplied by the device provides a 60-second automatically timed cycle consisting of an approximately 12-second inflation period followed by a 48-second period of relaxation. A pressure of 40mmHg is used for the calf, calfthigh and foot treatments. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.
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K Number
K182150Device Name
Devon 52 Sequential Compression Device
Manufacturer
Devon Medical Products (Jiangsu) Ltd
Date Cleared
2018-12-18
(132 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Devon Medical Products (Jiangsu) Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Devon 52 Series Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:
- Lymphedema
- Venous stasis ulcers
- Venous insufficiency
- Peripheral edema
Device Description
The Devon 52 Series Sequential Compression Device is a compression device based on sequential pneumatic compression technique.
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K Number
K173528Device Name
Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System
Manufacturer
Devon Medical Products (Jiangsu) Ltd.
Date Cleared
2018-02-06
(83 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Devon Medical Products (Jiangsu) Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Devon 24R deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).
This device can be used in the home or clinical settings to:
· Aid in the prevention of DVT
- · Enhance blood circulation
- · Diminish post-operative pain and swelling
- · Reduce wound healing time
· Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs
· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time
Device Description
Not Found
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K Number
K172030Device Name
Devon 51
Manufacturer
Devon Medical Products (Jiangsu) Ltd.
Date Cleared
2017-11-27
(145 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Devon Medical Products (Jiangsu) Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Devon 51 Series Sequential Compression Device is a compression device based on sequential pneumatic Compression technique which is intended for the treatment of the following conditions:
- Lymphedema
- Venous stasis ulcers
- Venous insufficiency
- Peripheral edema
The device is intended for both home and hospital use.
Device Description
The Devon 51 Sequential Compression device is a gradient compression pneumatic device used for treatment and management of venous or lymphatic disorders. The application of gradient compression is effective by increasing blood flow and encouraging extracellular fluid clearance. The system consists of a pump and a pair of four-chambered garments. The garments are available in different types and sizes. The pump provides cycles of compressed air at certain adjustable pressures and which sequentially inflates the garment from distal to proximal. When activated, air flows into the garment chambers, and the pump provides gradient pressurization to the chambers (with distal chambers inflated to a greater pressure than the proximal ones.) After each chamber is inflated, the pressure is held constant until all chambers are inflated in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats until the set therapy time is reached.
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K Number
K170814Device Name
Devon 24
Manufacturer
Devon Medical Products (Jiangsu) Ltd.
Date Cleared
2017-07-11
(116 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Devon Medical Products (Jiangsu) Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Devon 24 deep vein thrombosis prevention system is intended to be an easy to use portable by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).
This device can be used in the home or clinical settings to:
- · Aid in the prevention of DVT
- · Enhance blood circulation
- · Diminish post-operative pain and swelling
- · Reduce wound healing time
· Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs
· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time
Device Description
The Devon 24 deep vein thrombosis prevention therapy system (referred as Devon 24 below) is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). The Devon 24 system consists of a pair of pumps and sleeve assemblies.
The device will alternatively inflate and deflate the garment (sleeve) to stimulate blood flow in the extremities (muscle contraction). The device provides a 40mmHg pressure and followed by a deflation period once it reaches the desired pressure, each cycle time is 50 seconds.
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K Number
K161209Device Name
Cirona 6400
Manufacturer
DEVON MEDICAL PRODUCTS
Date Cleared
2016-05-31
(33 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
DEVON MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cirona 6400 disposable deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).
This device can be used in the home or clinical settings to:
· Aid in the prevention of DVT
- · Enhance blood circulation
- · Diminish post-operative pain and swelling
- · Reduce wound healing time
· Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs
· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time
Device Description
Not Found
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K Number
K151189Device Name
Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System
Manufacturer
Devon Medical Products
Date Cleared
2015-09-18
(137 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Devon Medical Products
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cirona 6300 disposable deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).
This device can be used in the home or clinical settings to:
- Aid in the prevention of DVT ●
- . Enhance blood circulation
- Diminish post-operative pain and swelling .
- Reduce wound healing time .
- Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs
- As a prophylaxis for DVT by persons expecting to be stationary for long periods of time
Device Description
The Cirona™ 6300 disposable deep vein thrombosis prevention system (refer as Cirona 6300 below) is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by simulating blood flow in the extremities (simulating muscle contractions). The Cirona 6300 system consists of a pair of pump and sleeve assemblies.
The device will alternatively inflate and deflate the garment (sleeve) to stimulate blood flow in the extremities (muscle contraction). The device provides a 50mmHg pressure and followed by 50 seconds of deflation period once it reaches the desired pressure.
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K Number
K151240Device Name
extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc
Manufacturer
Devon Medical Products
Date Cleared
2015-06-09
(29 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Devon Medical Products
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The extriCARE® Negative Pressure Wound Therapy gel strip is intended to be used in conjunction with extriCARE® 2400 and extriCARE® 3600 Negative Pressure Wound Therapy (NPWT) Systems, providing additional sealing if necessary.
The extriCARE®2400 and extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudates, infectious materials, and tissue debris from the wound bed. The extriCARE® 2400 and extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for the following wound types: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Device Description
extriCARE® Negative Pressure Wound Therapy Gel Strip
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K Number
K143362Device Name
extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister
Manufacturer
Devon Medical Products
Date Cleared
2015-02-03
(71 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Devon Medical Products
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The extriCARE® 3600 Negative Pressure Wound Therapy 1000cc canister is intended to be used in conjunction with extriCARE® 3600 Negative Pressure Wound Therapy (NPWT) Systems, adding to the original canister selections.
The extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudates, infectious materials, and tissue debris from the wound bed. The extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for the following wound types: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Device Description
Not Found
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