Red stamp with text FDA Approved

Medical grade vacuum erection devices for erectile dysfunction are regulated by the Food and Drug Administration (FDA).  They are classified as a Class II Medical Device. Buyers beware! There are currently hundreds upon hundreds of different ED pumps for sale. Price’s and design very quite a bit among the many available options. Despite numerous ED pump choices, there are currently only seven manufacturers who are registered as medical grade device manufacturers with the FDA. This fact might prove valuable when deciding which product to purchase. Click on the following link, Medical Grade Vacuum Erection Device to determine which manufacturers produce medical grade products. If the creator of the product you are considering to purchase is not registered on this website, the product is being marketed illegally to the public.

 

Does it matter if the ED pump you purchase is Medical Grade and legally marketed?

  1. An FDA registered manufacturer of a vacuum erection device must follow (GMP) Good Manufacturing Practices.
  2. As a manufacturer following Good Manufacturing Practices, Quality Assurance Programs and Quality Testing determine how these ED Pumps are produced and ensure high quality standards and safety for the men and women who use these products.
  3. The FDA routinely inspects these manufacturers to ensure compliance to the regulations, and to guarantee that adequate labeling and high safety standards are met.

 

Why are so may ED Pumps marketed illegally?

The FDA is responsible for oversight and regulation of medical devices and drugs.  Many Class II medical devices do not require Premarket Notification and fall under an existing 510(k) for a product. Manufacturers of vacuum erection devices, or their devices, can not be FDA approved but are deemed substantially equivalent to the original 510(k) issued in 1982. However, each manufacturer  must by law register with the FDA and comply with their guidelines.  Class II medical devices are not considered as dangerous to the public as many implantable devices or prescription drugs.  The FDA’s first priority are products that potentially have deadly side effects or present major health threats. This does not mean that ED Pumps do not have safety issues, because they can and do. Class II devices are generally thought to be less risky.  However, if you are considering an illegally marketed vacuum erection device it does not mean these products are safe or that the FDA will not shut down the manufacturer. It may mean the FDA has not yet audited the manufacturer. The MegaVac Sytem is an example of an illegally marketed and manufactured product in which the FDA took action.