(345 days)
The Nanma constriction rings (adjustable and stretchable) are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence. The Nanma constriction ring can be used alone or with a vacuum pump. This device is intended for over-the-counter use (OTC)
Nanma Adjustable and Stretchable Constriction Rings
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance described in a table, or any study details that prove the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Nanma Adjustable and Stretchable Constriction Rings."
The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed. It discusses regulatory classifications, general controls, and other compliance requirements, but does not include any performance data or study results.
To answer your request, I would need a document that specifically details the device's technical specifications, performance metrics, testing methods, and the results of studies conducted to demonstrate its efficacy and safety.
§ 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.