(240 days)
The Nanma non-adjustable constriction rings are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence. This device is intended for over-the-counter use (OTC)
Nanma Adjustable constriction ring
This document is a 510(k) premarket notification decision letter from the FDA for a device called "Nanma non-adjustable constriction rings." The letter states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain any information about specific acceptance criteria or a study that proves the device meets those criteria.
The letter is primarily focused on:
- Confirming the substantial equivalence determination for the device.
- Outlining the regulatory obligations and general controls provisions of the Federal Food, Drug, and Cosmetic Act.
- Providing contact information for various FDA offices.
- Stating the intended use of the device ("external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence" and "intended for over-the-counter use").
Therefore, I cannot populate the table or provide answers to most of the requested questions because the necessary information is not present in the provided text.
§ 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.