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510(k) Data Aggregation
K Number
K193020Device Name
VenaPro Vascular Therapy System
Manufacturer
Innovamed Health, LLC
Date Cleared
2019-12-04
(35 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Innovamed Health, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VenaPro Vascular Therapy System is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to:
- 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 and reduction of edema in the lower limbs.
The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.
Device Description
The VenaPro Vascular Therapy System is a lightweight, portable, rechargeable battery powered prescriptive device. It is intended to be used in the home or clinical setting by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT).
The system utilizes pneumatically controlled, single chamber cuffs actuated by an electronically controlled air pump unit and solenoid valve. All pump, battery and control components are protectively housed in a plastic case that is permanently attached to a single use inflatable cuff. A single tactile touch control switch, tri-color LED for ON, LOW BATTERY, CHARGING and CHARGE COMPLETED indication, and a blue LED (for indicating a leak or low pressure alarm) provides for user interface. There is also a port for connecting the battery charger/AC adapter plug, and a currently unused port for future use in usage data reporting.
The leg wrap (cuff) component consists of a Polyvinyl Chloride (PVC) air bladder encased inside a soft, non-woven medical fabric (a Polyester blended medical fabric) or equal , which is adhered to the PVC air bladder. The units are supplied clean, non-sterile, packaged in pairs (1 left and 1 right side).
In operation, the user simply turns the power ON via the single button I/O control switch. A single user "cuff" containing air bladders is permanently connected to the unit. The control unit then fills the cuff to a pre-determined pressure (50 mmHg). Cuff pressure is monitored by an internal pressure switch and system software. Once the pressure reaches the proper level, the pump is turned OFF for an approximately 50 second "rest" period, and the cuff deflates to ambient pressure through a valve inside the plastic case. After the "rest" period, the cycle repeats until the unit is turned off.
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K Number
K133274Device Name
VENA PRO
Manufacturer
INNOVAMED HEALTH, LLC
Date Cleared
2014-02-12
(111 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
INNOVAMED HEALTH, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vena Pro Vascular Therapy System, model VP-3111, is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to:
- 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 and reduction of edema in the lower limbs.
The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.
Device Description
The Vena Pro Vascular Therapy System is a lightweight, portable, rechargeable battery powered prescriptive device that is intended to be used in the home or clinical setting by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT).
The system utilizes pneumatically controlled, single chamber cuffs actuated by an electronically controlled air pump unit and solenoid valve. All pump, battery and control components are protectively housed in a plastic case that is permanently attached to a single use inflatable cuff. A single tactile touch control switch, tri-color LED for ON, LOW BATTERY, CHARGING and CHARGE COMPLETED indication, and a blue LED (for indicating a leak or low pressure alarm) provides for user interface. There is also a port for connecting the battery charger/AC adapter plug, and a currently unused port for future use in usage data reportung.
The leg wrap (cuff) component consists of a Polyvinyl Chloride (PVC) air bladder encased inside a soft, non-woven medical fabric made from Dupont Softesse (a Polyester blended medical fabric) or equal , which is adhered to the PVC air bladder. The units are supplied clean, non-sterile, packaged in pairs ( 1 left and 1 right side).
In operation, the user simply turns the power ON via the single button I/O control switch. A single user "cuff" containing air bladders is permanently connected to the unit. The control unit then fills the cuff to a pre-determined pressure (50 mmHg). Cuff pressure is monitored by an internal pressure switch and system software. Once the pressure reaches the proper level, the pump is turned OFF for an approximately 50 second "rest" period, and the cuff deflates to ambient pressure through a valve inside the plastic case. After the "rest" period, the cycle repeats until the unit is turned off.
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