DIE BJFAN! God I hate that guy.
CDRH Interim Regulatory Policy
for External Penile Rigidity Devices
"Vacuum pumps refer to devices which consist of a cylinder and a vacuum pump (either hand-operated or motorized). By placing the flaccid penis within the cylinder, this device creates an erection by applying a vacuum. This causes blood to enter the penis producing an erection. Once a satisfactory erection is obtained, the user often places a constriction ring around the base of the erect penis prior to removing the vacuum cylinder.
Information Relevant to Vacuum Pumps:
1. Consult your physician should any complications present, and discontinue use of the device if such conditions persist.
2. The user should apply the minimum amount of vacuum pressure necessary to achieve an erection.
3. The user should stop using the vacuum pump if pain occurs.
4. Vacuum pumps should not be used under the influence of alcohol or drugs.
5. Use of a vacuum pump may bruise or rupture the blood vessels either immediately below the surface of the skin or within the deep structures of the penis or scrotum, resulting in hemorrhage and/or the formation of a hematoma.
6. Misuse of a vacuum pump may aggravate already existing medical conditions such as Peyronie's disease, priapism, and urethral strictures.
7. Misuse of the vacuum pump could result in swelling of the penis and/or serious permanent injury to the penis.
8. Do not use an electrically powered vacuum pump in or near water."