A medical-grade penis pump (vacuum erection device) is a Class II medical device cleared by the FDA for treating erectile dysfunction. Unlike novelty products, a medical-grade system is manufactured to FDA design standards, with a vacuum limiter to prevent over-pumping and sizing options fitted to the individual. This guide explains how the devices work, the types available, how to choose one, and what the published research shows. Vacuum erection therapy is included among established ED treatment options by the 5th International Consultation on Sexual Medicine (Wang et al., Sexual Medicine Reviews, 2025) and a 2026 systematic review (Guillot-Tantay et al., French Journal of Urology, 2026).
This is educational content based on published peer-reviewed research. It is not medical advice. Clinical decisions should be made by the treating physician.
Benefits of using a medical penis pump?
External vacuum erection devices have become easily available for consumers since the FDA no longer requires a prescription from a physician to purchase a penis pump. Originally the device required a prescription when introduced in 1982. Prescription requirements were removed in 1997 when the FDA determined the medical penis pump as safe and highly effective.
Although prescriptions are no longer required, safety and quality issues are addressed by FDA guidelines and enforced by FDA inspectors. A medical device is held to high manufacturing standards. Pumps that are not medical grade may not work properly. They may also pose health risks to users of these products.
Clinical research, including a 2026 systematic review, supports vacuum erection devices as a validated non-drug option for managing erectile dysfunction (Guillot-Tantay et al., French Journal of Urology, 2026).
Men use erectile dysfunction pumps to avoid health risks or invasive procedures. Some of the benefits of using a medical penis pump may also include:
The treatment is not invasive and offers less adverse health risks compared to other treatments.
- Oral medications, like Viagra or Cialis, may not be an alternative for men taking high blood pressure medications, for example. Men who are diabetic, prostate cancer survivors, or are taking hypertension medication may use vacuum erection devices everyday as the only effective ED treatment based on their medical condition.
- Penile injections can leave scar tissue on the penis and be associated with side effects such as curvature of the penis known as Peyronie’s disease.
- Surgical penile implants are the most invasive form of treatment option. Surgical Implants are considered effective, but use of an external penis pump is often recommended as a first-line treatment.
- Shockwave therapy for ED is a popular new treatment to stimulate blood vessels in the shaft of the penis. However, the FDA considers this treatment experimental.
Penis pumps offer better cost-benefit when compared to other treatment options:
- Surgical penile implants are often as expensive as $15,000 or more for a complex surgical procedure. Shockwave therapy requires multiple in-office treatments and may cost many thousand dollars. For many men, a medical-grade penis pump offers a favorable balance of effectiveness and cost among ED treatment options.
The device may be recommended for penile rehabilitation:
- Penis exercise is now recognized to have various health and sexual benefits, and medical grade penis pumps may be recommended by urologists for it. Exercise sessions, referred to as penile rehabilitation, following prostate cancer procedures are considered effective ways to prevent shortening of the penis, penile shrinkage, and tissue atrophy.
Penis pumps may be used combined with other ED treatments:
- Most other treatments for erectile dysfunction can be improved by incorporating a penis pump to maintain an erection or increase fullness of the erection for sexual intercourse.
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Types of penis pumps
You have decided to purchase a penis pump and now you need to decide what type of device is right for you. What is the difference between a water penis pump and an air pump? How would an electric penis pump be useful compared to a hand pump? Why do some of these products seem expensive and some cheap?
- Water Penis Pump: Water penis pumps are not known as medical devices that follow FDA guidance documents as Class II penile rigidity devices. Water penis pumps use water rather than air. As they are designed to be used in water, they are better suited for use in the bathtub or shower than the bedroom. They are not commonly used for creating erections for sexual intercourse.
- Manual Penis Pump: Manual penis pumps use a manual operated pumping device that is connected to the cylinder. Manual penis pumps are the most commonly used devices.
- Electric Penis Pump: Electric penis pumps are a very common option. These devices are very effective for men who have arthritis or any issue that impairs the use of hands. Preference may also be a factor in choosing an electric pump over one operated manually. Otherwise, there is no real difference in the effectiveness of an electric penis pump.
FDA-registered products that meet quality and design standards are more effective and often have a higher price point.
Penis pump effectiveness depends upon your choice of device and initial willingness to experiment with options in accessories.
- Multiple cylinder-sizing options take into consideration natural differences in penis size. Determine if multiple cylinder sizes are available for the device you are considering.
- Tension systems, also known as constriction devices, are necessary to maintain a fully formed erection. Various designs, materials, and sizes of constriction rings are important to make sure the best combination of comfort and tension is achieved in erection maintenance.
In addition, beware of male enhancement products that make misleading claims. Penis enlargement is a claim often used out of context. A vacuum erection device that creates an erection will enlarge the penis from a flaccid to erect state. This is a reasonable expectation. No device is cleared by the FDA to enlarge an erection beyond its fullest natural state. These types of claims are not supported by published clinical studies. Products labeled in this way are likely novelty products or non-medical sex toys that can lead to physical harm due to over-pumping.
Research the variety of devices and types of accessory items before making a buying decision.
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How to use a penis pump
For best results with a penis pump, preparation is key and will allow you to create a full natural erection in 2-3 minutes. What type of preparation is necessary to have the best results?
- Make a commitment to yourself and to your partner to spend the time necessary to familiarize yourself with the device and the process of applying it before use for sexual intercourse. For men who have been unable to achieve an erection for multiple years this can be a two-week commitment to reconditioning blood vessels in the penis to handle blood. In other instances, several days or a number of practice sessions could be all that it takes to master the process.
- Trim pubic hair. Pubic hair potentially forms a barrier to creating a seal between the body and the device, which is necessary for creating a vacuum.
- Practice the process of applying just enough lubricant between the device and the body to create a seal. Also, the appropriate amount of lubricant inside the cylinder-opening and upon the head of the penis (glans penis) is basic, but makes all the difference once perfected.
- Learn which cylinder selection allows for the most efficient creation of the erection while comfortably fitting the fully-engorged erection.
- Tension systems, constriction devices, or penis rings, come in various sizes, designs, and are often made from different materials. The penis pump comes with several tension systems designed to be placed on the base of the fully erect penis to maintain the erection. Expect to experiment with various penis rings to find the best fit. Not every man is the same, and the seller should offer various options.
Now that expectations have been established, and you have gone through the preparation steps, using a penis pump is simple:

1. Apply the system over the penis.

2. Activate the pumping mechanism. This will draw blood into the penis, causing an erection.

3. Once the penis is fully engorged, the tension ring is placed at the base of the penis, maintaining the erection.
Watch this video for clear instructions on how to use a penis pump:
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Insurance Coverage
Medicare discontinued covering all external penis pumps in 2015. Most private insurance carriers have followed the course set by Medicare and during the past several years have phased out insurance coverage for any erectile dysfunction pumps.
Despite the lack of insurance coverage, the erectile dysfunction pump is among the most cost-effective forms of ED treatment. Insurance seldom, if ever, covers the cost of other ED treatments.
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Augusta Medical System – SomaTherapy Products
Urologists and sexual-health physicians in the United States and around the globe prescribe, refer, or recommend medical grade penis pumps manufactured by Augusta Medical Systems. Each SomaTherapy-ED™ vacuum erection device is designed and manufactured to FDA Class II standards.
Consumers trust products from Augusta Medical Systems for many reasons, including the fact that the company backs its penis pumps with a lifetime warranty.
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