Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.5021
Review panel
GU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.