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The Nanma Vacuum Pump is an external penile rigidity device designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pump is used to create erections in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)

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This document is a marketing clearance letter for a medical device called the "Nanma Vacuum Pump ProXZEK, Model 2M9498S". It is a 510(k) clearance, which means the FDA has determined the device is substantially equivalent to legally marketed predicate devices, and therefore does not require a premarket approval (PMA) application.

A 510(k) clearance does not typically involve a new clinical study to establish acceptance criteria and prove performance in the same way a PMA does. Instead, it relies on demonstrating equivalence to an existing device. Therefore, the information requested regarding acceptance criteria and a study proving the device meets them, particularly with details like sample sizes, ground truth establishment, and MRMC studies, is not contained within this particular document.

This document primarily states the device's Indications for Use:
"The Nanma Vacuum Pump is an external penile rigidity device designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pump is used to create erections in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)."

The basis for this clearance is a comparison to a predicate device, and the "proof" is the demonstration of substantial equivalence, not a direct clinical trial with specified acceptance criteria as would be found in a PMA.

Therefore, for your specific request, most of the information cannot be extracted from this 510(k) clearance letter.

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