(75 days)
The Nanma non-adjustable constriction rings are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence.
Nanma non-adjustable constriction ring
This document is a 510(k) clearance letter from the FDA for the 'NANMA Non-adjustable Constriction Ring'. It does not contain information about the acceptance criteria, study details, or device performance metrics as requested in the prompt. The letter confirms substantial equivalence to a predicate device and permits marketing, but it does not include clinical trial data, sample sizes, expert qualifications, or ground truth establishment.
§ 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.