Medical disclaimer
External penile rigidity devices, the federal category that includes vacuum erection systems, are classified under 21 CFR §876.5020. A category reference does not state that a particular SmartTract product is FDA cleared or approved. This page is educational and is not a substitute for professional medical advice. Consult a qualified clinician before use, especially if you have a history of prostate surgery, a bleeding disorder, sickle cell disease, reduced sensation, or take anticoagulant medication.