FDA REGISTRATION

The FDA Designates the vacuum pump as a medical device subject to general control provisions of the food an drug cosmetic act of 1997 and the code of federal regulation, Title 21, Part 800+895, include quality system regulations on current good manufacturing practices.

The FDA approved  intended use: An external penile rigidity device, including vacuum pump and constricting rings which is intended to create and maintain penile erection in impotent men for the treatment of impotence and premature ejaculation.