FDA Classification of Penis Pumps

FDA-approved penis pumps are external penile rigidity devices that follow the recommendations or equivalent measures of the Food and Drug Administration to address risks of safety and effectiveness.

The FDA defines a penis pump as an external penile rigidity device intended to create or maintain sufficient penile rigidity for sexual intercourse consisting of a cylinder and vacuum pump which is either manually hand operated or electrically motorized.

FDA Identification of Risks Associated with Penis Pumps

The FDA identified two (2) risks to health associated with the use of a vacuum pump as:

1. Tissue injury, trauma, or infection
2. Aggravation of existing medical conditions such as Peyronie’s disease, priapism, and urethral strictures

FDA Recommendations to Minimize Risks

The FDA recommends two (2) primary mitigation measures to minimize risks of vacuum pumps: design features and labeling.

Design Features

1. Manual Safety Mechanisms
Vacuum devices should include a manually operated button to quickly release all vacuum pressure in the cylinder.

2. Vacuum Level
Vacuum devices should include an automatic safety valve to limit vacuum pressure to safe levels.

3. Shape and Surface Design
Vacuum devices should have smooth surfaces and shapes.

4. Electrical Safety
Electrically powered vacuum devices should have adequate electrical isolation between the user and the power source of the device.

Labeling

5. Instructions for Use
Vacuum pumps should have easily accessible and comprehensive instructions for use including illustrations, overviews, how-to-use steps, troubleshooting, and intended uses.

6. Warnings
Vacuum pumps should include warning labels about potential risks associated with the devices.

7. Precautions
Vacuum pumps should include additional precautionary measures to take to minimize risks.

Regular Penis Pumps

There are a total of seven (7) main criteria that the FDA uses to classify a penis pump as FDA-approved listed above. We will discuss each of the seven (7) criteria below, and how they apply to regular penis pumps.

1. Manual Safety Mechanisms

All regular penis pumps sold on PPOnline are equipped with a manually-operated button that quickly releases all vacuum pressure in the cylinder. This is a very important feature that allows you to stop your session if you feel any discomfort or pain.

2. Vacuum Level

Regular penis pumps typically do not come with an automatic safety valve that limits vacuum pressure in the chamber. This is because men use penis pumps for different purposes.

Penis pumps are used to help treat erectile dysfunction, penis enlargement, sexual stimulation and exploration, dominance and BDSM, and many other purposes.

Therefore, many regular penis pumps simply come with warnings, labels, and instructions for use, so men can use their pumps as they wish while understanding the uses and risks of the device.

3. Shape and Surface Design

Regular penis pumps are designed and manufactured to have smooth surfaces and rounded designs for enhanced safety and ergonomic functionality.

Manually hand-operated pumps or electrically motorized pumps typically have an ergonomic and smooth textured control device to operate the pump.

They also have smooth-surfaced cylinders and a wide cylinder opening with a flat lip for a comfortable pumping experience.

4. Electrical Safety

Electrically powered motorized penis pumps typically have their motorized electrical systems away from the body and at the other end of the cylinder.

5. Instructions for Use

All regular penis pumps come with instructions for use which include an overview, illustrations, warnings, and intended uses.

Additionally the cylinders are ruler-imprinted or ruler-labeled so you can monitor the penis during the session for safety.

6. Warnings

View all penis pump warnings here.

In addition to the warnings included with the penis pump, we have a list of all FDA warnings, precautions, and risks associated with penis pumps above.

7. Precautions

View all penis pump precautions here.

In addition to the precautions included with the penis pump, we have a list of all FDA warnings, precautions, and risks associated with penis pumps above.

Conclusion

Penis pumps are powerful devices. Proper instructions, warnings and precautions need to be followed before and while using them.

While FDA-approved penis pump devices have a list of seven (7) criteria they have to meet for approval, regular penis pumps sold at PPOnline meet six (6) of the criteria and are highly vetted and curated devices.

The only criteria PPOnline penis pumps don't meet is a valve that automatically limits the pressure in the cylinder.

The reason for not including a valve that automatically limits the pressure in the cylinder is because some men may want to use the pump for various reasons, and the pressure limit the FDA enforces is very low.

Instead of limiting what our customers can do with their purchased penis pumps, we would rather provide knowledge, charts, and routines for them to safely use their devices.

Our kPa to inHg pressure conversion chart allows you to accurately monitor the pressure you're using and can be found here.

We offer a few routines for you to get started here such as our warmup routine and starter routine.

Overall, the penis pumps at PPOnline meet six (6) of the seven (7) criteria for FDA approval, and we intentionally do not meet the last criteria to give our users more freedom and flexibility with how they want to use their pump.

We also provide our users with charts, data, and safety information, so they can make the best informed decision for themselves.

And PPOnline penis pumps cost a fraction of an FDA-approved penis pump that is normally sold for a few hundred dollars. View our full collection of penis pumps here.

Contact us at hello@penispumpsonline.com if you have any questions or comments!