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FlowKeepers®

How it Works

Clinical Studies

Worn on the calves, FlowKeepers® help improve blood flow in your lower legs, while you rest, sleep or sit for long periods of time.*

wearing flowkeepers
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Cleared for use by the United States FDA.

This medical device was included in 4 clinical trials. The studies indicate improved venous and arterial blood flow in the participants.*

Pumps blood every 10 seconds with a gentle pulse.

This can result in improved heart function, and oxygenation of the tissues.* Furthermore, this will instantly soothe discomfort in the legs.*

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Clinical Study: up to 5X Increase in Venous Blood Flow
Ten healthy volunteers, ages 28-67 were recruited to affix the FlowKeepers device to their right calf muslce about 2 inches below the knee. A baseline Doppler ultrasound measurement of the central femoral venous blood flow was made with the device inactive. Subsequent measurements were made with the device activated, with the volunteer in various positions. FlowKeepers was shown to significantly increase venous blood flow of the lower extremities, measured by central femoral vein Doppler flow velocity studies, in all positions tested including recumbent, sitting with and without compression, and standing. The average venous flow velocity while wearing FlowKeepers was approximately 5 times more than baseline, in erect position. Increases in flow at ALL positions were improved by statistically significant margins.*
Clinical Study: 15-25% Swelling Reduction

Ten volunteers with ankle edema of various etiologies were studied at baseline and after wearing FlowKeepers for 12-24 hours. Five participants had swelling of one leg only, and 5 participants showed bilateral edema. Both limb volumes were evaluated by fluid displacement before and after the stimulation period using FlowKeepers. Both groups of participants showed a statistically significant mean volume reduction (approximately 15% reduction in the bilateral group of participants, and 25% in the unilateral group) – this after wearing the medical device for 12-24 hours, depending on the individual. Researchers concluded that FlowKeepers® is a fast, and potentially very effective method of reducing fluid buildup of the legs or ankles.*

Clinical Study: Up to 39% Tissue Oxygenation Increase
This study was designed to evaluate the effect of FlowKeepers on patients with chronic leg ulcers. People who are sedentary often develop slow-healing wounds or ulcers on their legs due to reduced tissue oxygenation of the feet. A study at the Wound Care Center of Norwalk Hospital in Connecticut showed significant increases in tissue oxygenation levels.* The measurement was determined using transcutaneous oxygen pressure (tcpO2), a non-invasive method that quantifies skin oxygenation. Six participants were enrolled, of which 5 had chronic, leg or foot ulcers. One was a healthy volunteer. Two measurement sites were taken in each person. Following FlowKeepers use for 30 minutes, tcpO2 increased from 34.2 to 47.7 mmHg in the ulceration group, and 45 to 54 mmHg in the healthy volunteers.
Clinical Study: Wakefulness & Performance

This study was designed to evaluate wakefulness and performance in the sleep deprived. Performance of pilots, air traffic controllers, key military and security personnel are impacted by sleep deprivation. Driver sleepiness is a causative factor in 30% of all U.S. motor vehicle crashes and 21% of fatal crashes. Certain factors increase sleepiness such as diminished sensory input and increased splanchnic circulation. Thus, providing sensory stimulation and enhanced peripheral circulation and venous return, might help fight sleepiness. FlowKeepers® was found to help maintain wakefulness and improve performance in healthy, sleep deprived individuals.* We surmise the benefit may be related to ongoing sensory and motor activation, along with enhanced peripheral circulation.

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FDA cleared as powered muscle stimulator for temporary improvement of local blood circulation in healthy leg muscles. Clinical observations support FDA cleared indications. Results may vary.

Instruction Videos

FlowKeepers® is an FDA cleared device that is specifically designed to be applied to the calf and treat the lower legs. FlowKeepers® is unique in how it operates. Please watch the videos to learn more about FlowKeepers® or download the user’s guide.
user guide

GETTING STARTED

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INSERT BATTERIES

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ATTACH GEL PADS

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USING THE DEVICE

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ADJUST POWER SETTINGS

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OTHER LEG

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REMOVAL AND STORAGE

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If you have questions or need help, please call 302-388-5016.

Product Videos

FlowKeepers® is an FDA cleared device that is specifically designed to be applied to the calf and treat the lower legs. FlowKeepers® is unique in how it operates. Please watch the videos below to learn more about FlowKeepers® or email us your questions at info@flowkeepers.com.

A Word of Caution

Please review addtional important caution and warning statements in users guide.

Do NOT use the device if you are:

  • Suffering from an acute DVT (Deep Vein Thrombosis)
  • Allergic to electrode gels
  • Pregnant
  • Under the age of 18
  • Have a pacemaker or ICD (Implantable Cardioverter Defibrillator)
  • Have implanted devices (consult your physician first)
  • Have broken or infected skin near the patch placement area

Contraindications:

  • Powered muscle stimulators should not be used on patients with cardiac demand pacemakers

Warnings:

  • The long-term effects of chronic electrical stimulation are unknown.
  • Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex.
  • Stimulation should not be applied over the neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur, and the contractions may be strong enough to close the airway or cause difficulty in breathing. Stimulation should not be applied transthoracically, in that the introduction of electrical current into the heart may cause arrhythmias.
  • Stimulation should not be applied trans-cerebrally.
  • Stimulation should not be applied over swollen, infected or inflamed areas or skin eruptions, e.g. phlebitis, thrombophlebitis, varicose veins, etc.
  • Stimulation should not be applied over, or in proximity to, cancerous lesions.

Precautions:

  • Safety of powered muscle stimulators for use during pregnancy has not been established.
  • Caution should be used for patients with suspected or diagnosed heart problems.
  • Caution should be used for patients with suspected or diagnosed epilepsy.
  • Caution should be used in the presence of the following:
    • When there is a tendency to hemorrhage following acute trauma or fracture
    • Following recent surgical procedures when muscle contraction may disrupt the healing process
    • Over the menstruating or pregnant uterus
    • Over areas of the skin which lack normal sensation.
  • Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrically conductive medium. The irritation can usually be reduced by using an alternate conductive medium, or alternate electrode placement.
  • Electrode placement and stimulation settings should be applied according to the included manufacturer’s directions or the guidance of your practitioner.
  • Powered muscle stimulators should be kept out of the reach of children.
  • Powered muscle stimulators should be used only with the leads and electrodes recommended for use by the manufacturer.
  • Portable powered muscle stimulators should not be used while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury.

Adverse Reactions:

  • Skin irritations and burns beneath the electrodes have been reported with the use of powered muscle stimulators.