(88 days)
The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with Erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.
Not Found
This document package is a 510(k) premarket notification decision letter from the FDA regarding a vacuum erection device. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter primarily states that the device, named "Boss-2000-3 Vacuum Erection Device (Over-the-Counter Use)", is substantially equivalent to legally marketed predicate devices and can therefore be marketed.
Therefore, I cannot provide the requested information.
§ 876.5020 External penile rigidity devices.
(a)
Identification. External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.(b)
Classification. Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.