(245 days)
The Nanma Vacuum Pumps are external penile rigidity devices designed to promote The Namma Vacuun I umps are extenzi points agency and supers are used to create erections in men with erectile dysfunction.
Nanma Vacuum Pump
This document does not contain information about acceptance criteria or a study proving a device meets those criteria. The provided text is a 510(k) clearance letter from the FDA for a Nanma Vacuum Pump, indicating substantial equivalence to a predicate device. It specifies general information about regulatory classification, compliance, and marketing, but does not detail performance studies or specific acceptance criteria.
§ 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.