QWW

Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.

Product code

QWW

Device name

Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.

Device class

Class 2

21 CFR

21 CFR 876.5021

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

A non-medicated topical formulation for treatment of erectile dysfunction is a device that is applied on the penis and stimulates the nerve endings by inducing a temperature change, leading to tumescence and erection.

Definition text from the FDA device classification database (U.S. federal government work, public domain).