For over the past 35 years we have worked directly with prescribing physicians, product users, and clinical educators around the world to manufacture, define and re-define the best penis pump. Through the years, multiple new technologies created by the founders of Augusta Medical Systems have produced the following brands:
- Vitality OTC Manual
- Vitality Plus Battery
- Elite Custom
- Response II
- Touch II
- SOMAcorrect Xtra
- Soma Correct for Peyronie’s (Europe)
- Soma Therapy OTC Manual
- Soma Therapy OTC Premium
- SOMAerect Stf
- SOMAerectStf Plus
A penis pump is a class II medical device described by the FDA as an External Penile rigidity device. These devices are also known as vacuum erection devices, a negative pressure device, erectile dysfunction pumps, vacuum constriction device or a vacuum therapy device. They are used to create and maintain an erection.
The following components are assembled to create a penis pump:
The specially designed lever can be activated with one finger for effortless creation of vacuum or negative pressure. It is called the Ultra Ease™ lever. The vacuum head is used to create vacuum.
The black button featured on the back of the vacuum head is a release button which instantly releases all vacuum in the cylinder.
The AMS Battery Negative Pressure Device is available for men who want to create vacuum with the touch of a button.
The penis is inserted into the cylinder(s) and vacuum creates an erection. Five cylinders are available to accommodate anatomical differences that naturally exist from man to man. The Soma Therapy OTC Manual system and the Soma Therapy OTC – Premium both come with the most commonly used cylinder. SOMAerectStf and SOMAerectStf Plus both come with the 3 interlocking cylinders. Additional cylinders are available via special order. Utilizing the cylinder that most closely matches your fully engorged erection allows for the most efficient use of vacuum and easy creation of full penile rigidity. The unique Stf product line excels in vacuum efficiency!
Tension System or Rings
Used to hold or maintain an erection. The precise balance of tension and comfort is necessary to maintain an erection. The SureFit™ collection of tension systems comes with each vacuum therapy device. In addition to the SureFit™ collection the following comprehensive selection is available:
Soft adjustable inserts fit on the end of the cylinder. Comfort inserts also slightly decrease the diameter of the cylinder to further customize the cylinder for a snug fit against the body then applying the system.
Specially developed for Augusta Medical Systems vacuum therapy systems. To ensure optimal performance in achieving an erection.
Apply the system over the penis
Squeeze the lever 3-5 times, wait 10-15 seconds, repeat the process until the penis is fully engorged.
Once you have achieved a full erection, slide the tension system to the base of the penis, maintaining the erection while removing the cylinder.
Superior product performance, unequaled quality standards and well thought-through design features all make for a first-rate user experience and successful treatment outcomes. A commitment to continuous product improvement has evolved to create the finest medical penis pump products, known as the SOMA product line.
Physicians prescribe and continue to refer Soma Therapy-ED products to their patients on a daily basis to treat erectile dysfunction around the globe. Before Medicare discontinued coverage of the penis pump in the United States a.k.a as the vacuum erection device or erectile dysfunction pump in 2015, prescriptions were necessary for Medicare and private insurance reimbursement which has all but disappeared since 2015.
Urologist at the following institutions have referred or prescribed Soma Therapy-ED:
- MD Anderson Cancer Center
- Cleveland Clinic
- Memorial Sloan Kettering Cancer Center
- Mayo Clinic
- John Hopkins Medicine
- City of Hope
- Kaiser Permanente
- Duke University School of Medicine
- Mount Sinai
- Grady Memorial Hospital
* Prescriptions are not endorsements, none of the above intuitions are endorsing Augusta Medical Systems or Soma Therapy-ED
Subject to the September 10, 1997 FDA policy modifications, Penile Rigidity Devices manufactured for sexual pleasure do not have to register or be listed with the FDA so long as their products “do not make medical claims.” Those companies who do not list with the FDA, are not routinely inspected for Good Manufacturing Practices and the Quality System Regulation by the FDA, thus they are flying under the radar.
Prior to 1997 all penis pumps were required to strictly adhere to good manufacturing practices and the quality system regulation which required devices and the manufacturers that produced them to submit to audits of their devices and quality systems. Strict adherence to design features and labeling claims were in place to prevent risks to the health of men who use these types of products.
It is now difficult for men to differentiate between medical devices and sex toys. On-line sites don’t do much to help direct men toward medical devices and away from toys.
Finding reliable unbiased ratings of penis pump products on-line is difficult. Medical professionals who prescribe these products don’t normally participate in comprehensive product ratings. Augusta Medical Systems distributes its products by physician referrals and/or prescriptions. Otherwise you can buy direct from Augusta Medical Systems.
Affiliate marketing sites or one-line retailers use product ratings as a popular way to give high ratings to the products that they earn a commission on or promote a sale of. Examples of sites that rate penis pumps are:
- Austin Review which is an affiliate marketing site for Penomet, and Hydromax which both are a form of water penis pump.
- Penis Pump Advice is another affiliate marketing site which rates water penis pumps.
Clinical studies clear medical penis pumps for two primary labeling claims:
- To create penile rigidity
- For penile rehabilitation
When a novelty product or sex toy begins to make medical claims and venture outside of the intent of the 1997 non-prescription FDA ruling, with claims such as treating erectile dysfunction, they maybe unadulterated or unapproved claims. Over-promising and under-delivering has become common in the market for penis pumps. As soon as you see claims that are in fact medical, buyer beware!
The following medical claims associated with a penis pump in the United States are not backed up by science and depending on the context of the claim may in-fact violate the FDA claims guidelines:
- Penis Enlargement Pump
- Premature Ejaculation Treatment
- Peyronie’s Disease Treatment
- Increase Penis Length
Penis enlargement pumps may intentionally or unintentionally encourage a user to over pump to gain penile length. The FDA lists the following outcome that can be directly related to over-pumping.
Device use may bruise or rupture the blood vessels within the penis or scrotum, resulting in petechiae (a small purplish spot on a body surface, such as the skin or a mucous membrane, caused by a minute hemorrhage), hemorrhage (flow of blood from ruptured blood vessels), or the formation of a hematoma (localized swelling filled with blood resulting from a break in a blood vessel).
Devices that meet FDA design features have a manual safety release mechanism. Further, FDA design features mandate that vacuum pumps draw a vacuum of less than 17 inches of mercury. This also can prevents damage to the penis caused by over-pumping.
Penis pumps are designed to increase blood flow to the penis. The best penis pumps can achieve this efficiently, comfortably, and with high levels of consistent predictability. Augusta Medical Systems has proven that it manufactures the best penis pump. Our testimonials are from men just like you. For more information please give us a call at 800-827-8382.