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510(k) Data Aggregation
K Number
K241096Device Name
Venera 608 Deep Vein Thrombosis (DVT) Prevention System
Manufacturer
Suzhou Minhua Medical Apparatus Supplies Co., Ltd
Date Cleared
2025-01-15
(268 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Product Code :
JOW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Venera 608 Series system 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, urologic, obstetric conditions and treatments.
Device Description
The Venera™ 608 Series deep vein thrombosis prevention system is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life-threatening condition. The Venera™ 608 Series system consists of a device and a pair of soft compression cuff(s) (sleeves) and the extension tubing set for the calf, calf-thigh, and foot. The device will alternatively inflate the two cuffs and mimic the natural walking pace in order to enhance circulation. The device-supplied compression 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, calf-thigh, and 120mmHg for foot treatments. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.
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K Number
K240499Device Name
ARTAIRA Arterial Compression Device (AACD01)
Manufacturer
AIROS Medical, Inc.
Date Cleared
2024-10-11
(234 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Product Code :
JOW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ARTAIRA Arterial Compression Device's is an intermittent pneumatic compression device intended for treatment of patients with the following conditions:
- · Intermittent claudication
- · Rest pain
- Diabetic Foot
- · Ischemic neuritis
- · Arterial ulcers
- · Gangrene
- Poor runoff.
Device Description
The AIROS ARTAIRA Arterial Compression Device is an intermittent pneumatic compression device intended to increase blood flow and increase circulation in the lower extremities by providing timed compression to the foot/ankle and calf. The device consists of a hard casing with an air pump, a set of air valves, an air reservoir controlled by the device software to deliver a rapid burst of pneumatic pressure to the treatment area. The device connects through air tubing to a pair of compression garments (left and right leg), each with two air chambers: one on the underfoot (Foot/Ankle chamber) and one on the calf area (Calf Chamber). The device can either be used with one garment or two garments. The system is intended to be used primarily at home settings according to a physician-prescribed therapy.
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K Number
K241746Device Name
UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF
Manufacturer
United Medical Resources LLC
Date Cleared
2024-10-04
(108 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Product Code :
JOW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UMED REPROCESSED CTC VP 520 FOOT CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home.
The UMED REPROCESSED CTC VP 501 CALF CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home.
The UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 / 3050 is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in at-risk patients in order to prevent deep vein thrombosis (DVT) and. The device is a prescription device for the use in a clinical setting or in the home.
The UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home.
The UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in at- risk patients in order to prevent deep vein thrombosis (DVT). The device is a prescription device for the use in a clinical setting or in the home.
Device Description
Not Found
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K Number
K232640Device Name
Venowave VW5
Manufacturer
Thermabright
Date Cleared
2024-06-25
(305 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Product Code :
JOW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Venowave VW5 series of devices are prescriptive and induce improved vascular and lymphatic flow of the lower limbs. Venowave device are intended to treat the following:
Indications for Use:
- Management of the symptoms of post thrombolytic syndrome (PTS)
- Prevention of deep vein thrombosis (DVT)
- Prevention of primary thrombosis
- Treatment of lymphedema
- Diminishing post-operative pain and swelling
- Treatment of leg swelling due to vascular insufficiency
- Treatment of varicose veins
- Treatment of chronic venous insufficiency
- Enhancing blood circulation
- Treatment of intermittent claudication
Device Description
The Venowave VW5 is a series of compact, battery-operated peristaltic pumps that generate a wave-form motion, and when worn below the knee strapped firmly to the calf, result in compression of the calf and consequently, an increased upward volumetric displacement of venous and lymph fluid. Each of the models within the family (VW5-6;VW5-10; VW5-20; and VW5-30) is distinguished by the maximum number of times the wave plate cycles each minute (6, 10, 20 and 30 cycles/minute respectively). Clinical preference to choose a specific frequency of motion for each specific patient based upon that patient's clinical symptoms, severity of disease, and perceived compliance with treatment has been the motivation for creating each model within the series.
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K Number
K234155Device Name
Nimbl (model PD08-N1)
Manufacturer
Tactile Medical
Date Cleared
2024-06-21
(175 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Product Code :
JOW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nimbl system is intended for use by medical professionals and patients who are under medical supervision, for the treatment of the following conditions: - Chronic edema - Lymphedema - Venous insufficiency - Wound healing
Device Description
The Nimbl system is a pneumatic compression device that delivers intermittent sequential compression treatment to affected extremities for lymphedema, chronic edema, venous insufficiency, and wound healing. This device helps direct and move excess fluid from an impaired lymphatic region to healthy regions, where fluid can be absorbed and processed naturally by the body. The Nimbl controller is used to inflate the connected garment chambers in a pre-programmed sequence from the distal end to the proximal end of the patient. The pressure gradient provides higher distal pressures. This creates a dynamic wave of therapy that directs fluid into the lymphatic capillaries while maintaining distal prevent distal backflow. The patient's healthcare provider determines what pressure setting is appropriate for the patient.
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K Number
K240125Device Name
Therm-X (Home); Therm-X (AT)
Manufacturer
Zenith Technical Innovations
Date Cleared
2024-06-21
(157 days)
Product Code
JOW, ILO, IRP
Regulation Number
870.5800Why did this record match?
Product Code :
JOW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Therm-X (Therm-X Home and Therm-X AT) combines cold, heat contrast, and compression therapy. Therm-X (Therm-X Home and Therm-X AT) is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surqical conditions for which localized thermal therapy (hot or cold) are indicated. The Therm-X (Therm-X Home and Therm-X AT) is also intended for treatment of disorders associated with vascular or lymphatic insufficiency, such as lymphedema and chronic venous insufficiency (CVI).
Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.
Therm-X (Therm-X Home and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.
Device Description
Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription, or supervision of a licensed healthcare professional. The device is available in two configurations: Therm-X Home and Therm-X AT.
Therm-X (Therm-X Home and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. The Therm-X Home system also provides DVT prophylaxis therapy and continuous therapy for users who wish to receive treatment over an extended period of time.
Therm-X (Therm-X Home and Therm-X AT) consists of various reusable inflatable wraps for thermal treatment of the back, elbow, hand/wrist, shoulder, ankle, hip, lower leg, or knee and DVT prophylactic treatment applied to the foot or calf. Multi-patient use garments are available for all anatomical areas that can be cleaned and disinfected in between uses to be reused for different patients. Single-patient use garments are available for thermal treatment of the back, hand/wrist, shoulder, neck, ankle, hip, and knee and can be disposed of after patient treatment is concluded. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with or without pneumatic compression. The foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by the Therm-X Home system only.
Therm-X (Therm-X Home and Therm-X AT) is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature, and compression settings. Therm-X AT and Therm-X Home models provide an optional password protection feature that allows for a user to use only stored cycles, giving health care providers an ability to ensure compliance to a chosen cycle. The device also provides functionality to allow the health care provider to assign a date at which the user will be able to access a second stored cycle instead of the first. The Therm-X device also allows users to chanqe treatment pressure and temperatures to less extreme therapies (e.g. changing a warm cycle to a lower warm temperature or changing a cold cycle to a higher cold temperature).
Therm-X (Therm-X Home and Therm-X AT) is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.
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K Number
K232270Device Name
DVT Motion Pneumatic Compression Device
Manufacturer
Koge Micro Tech Co., Ltd.
Date Cleared
2024-03-06
(219 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Product Code :
JOW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DVT Motion Pneumatic Compression Device is a prescription device intended for prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in the prevention of venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital setting.
Device Description
The DVT Motion Pneumatic Compression Device is a portable, rechargeable battery-powered device intended for prescribed home use or hospital use to help prevent Deep Vein Thrombosis (DVT) in patients by stimulating blood flow. This is accomplished using an electronically controlled pump delivering a set amount of air to the leg garment that compresses the calf and aids blood flow through the lower extremities. The pump will inflate to a preset pressure of 50mmHg and deflate once this pressure is reached. The cycle continues until the unit is turned off. The tube free solution comes complete with a fully integrated lithium ion battery that supplies over 18 hours of treatment on a single charge, assuring that patients can be transported easily from the hospital to their homes without interruptions in treatment.
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K Number
K240011Device Name
Lymphedema Compression
Manufacturer
JKH Health Co., Ltd.
Date Cleared
2024-02-23
(52 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Product Code :
JOW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lymphedema Compression is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. It is pre-set to the default setting of 50 mmHg that cannot be adjusted or can be adjusted by the physician to a pressure within the specified range. It is intended for use in:
- Treatment of lymphedema
- Treatment of chronic venous insufficiency
- Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
- Reducing venous leg ulcer healing time
- Reducing edema due to venous stasis
- Enhancing venous return
The device is intended for home, and hospital use.
Device Description
As a portable and rechargeable prescriptive device, the Lymphedema Compression is intended to be used in the home or clinical/hospital setting by or under the direction of a medical professional. It applies pressure to treat lymphedema and other edematous conditions.
Supplied clean and non-sterile, the Lymphedema Compression utilizes the pneumatically controlled cuff and is actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively housed in a plastic case of the control unit, which is attached to an inflatable cuff/sleeve. The Lymphedema Compression contains an ON/OFF button, a SET button, and a display for user interface. In addition, there is also a port on the control unit for connecting the battery charger/AC adapter plug. The cuff component consists of multiple air chambers/bladders encased inside a soft nylon fabric or equivalent biocompatible fabric for increased patient comfort and biocompatibility compliance.
In operation, the user simply press the ON/OFF button to turn on the control unit, to which a cuff containing air chambers/bladders is connected. And the control unit then inflates the cuff to the default pre-determined pressure (50 mmHg) that cannot be adjusted to a pressure within the specified range via the SET button. Once the cuff pressure of the multiple air chambers/bladders reaches the pre-determined or adjusted level, the pump is turned off, and the cuff deflates to the ambient pressure through a valve inside the control unit. After the rest period, the cycle of inflation and deflation repeats until the device is turned off automatically or manually.
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K Number
K223228Device Name
Dayspring
Manufacturer
Koya Medical, Inc.
Date Cleared
2024-01-04
(443 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Product Code :
JOW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Koya Dayspring system is a prescription only wearable compression system that is intended for use in a clinic or home setting by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as:
- · Lymphedema
- · Primary lymphedema
- Post mastectomy edema
- · Edema following trauma and sports injuries
- · Post immobilization edema
- · Venous insufficiency
- · Reducing wound healing time
- · Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers
- · Lipedema
- Phlebolymphedema
Device Description
The Dayspring system consists of two main components: a controller and garment is powered by an active smart compression technology that is calibrated, instant-acting, and silent. This technology uses a Nickel Titanium (Ni-Tì) shape-memory alloy the controller. A liner or lite weight clothing is worn under the garment to prevent direct patient contact with the garment is wrapped around the patient's affected area so that the device fits snugly. The device has independently controlled sections in each limb. The controller can be programmed to provide graduated sequential compression therapy to the affected area over a range of 0-100 mmHg. The device is powered by a rechargeable Lithium-ion battery pack. The device was developed to provide patients with untethered access and a functional range of motion and mobility.
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K Number
K232300Device Name
ElastiMed SACS
Manufacturer
ElastiMed Ltd.
Date Cleared
2023-12-22
(143 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Product Code :
JOW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ElastiMed's SACS device is a portable and lightweight device intended to provide compression in both sustained and intermittent settings by stimulating blood flow in the legs. The SACS device is intended for:
- -Aid in the prevention of DVT.
- -Enhance blood circulation.
- -Diminish post-operative pain and swelling.
- -Reduce wound healing time.
- -Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, chronic lymphedema, and reduction of edema in the lower limbs.
- As a prophylaxis for DVT by persons expecting to be stationary for long periods of time. -Reduction of edema associated with soft tissue injuries, such as burns, postoperative or postimmobilization edema or ligament sprains.
The device can be used in the home or clinical setting.
Device Description
The ElastiMed SACS is a lightweight, portable, rechargeable battery powered device, aiding in the stimulation of blood flow in the lower limb through sequential compression.
The SACS device imbeds three Electro Active Polymer (EAP) straps, that sequentially stretch and contract when stimulated by an electric charge. The timely sequential upward contractions of the straps compress the limb, allowing for the repetitive squeezing and relieving actions that mimic normal muscle contractions. The device is supplied with a rechargeable battery which is incased in the fabric casing, and a microprocessor which is imbedded within the control box, located at the front of the unit. The one touch operation control box also imbeds a buzzer, LED light indicator, micro speaker, and a micro-USB port (for charging). The device can be used in the home or clinical setting.
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