(458 days)
The Nanma Vacuum Pumps are external penile rigidity devices designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pumps are used to create erections in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)
Nanma Vacuum Pumps Models 2M995, 2M438 .M330/3R. and 2M265
This document is a 510(k) clearance letter for the Nanma Vacuum Pump. It does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study in the same way a PMA or de novo submission might.
Therefore, I cannot provide the requested information from this document. The document primarily confirms that the FDA has reviewed the manufacturer's premarket notification and determined that the Nanma Vacuum Pump is substantially equivalent to legally marketed predicate devices for the indicated uses.
§ 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.