Device |
non-medicated topical formulation for treatment of erectile dysfunction. |
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. |
Physical State |
Non-medicated formulation designed to stimulate the nerve endings in the penis. |
Technical Method |
Stimulation of nerves in penis through induced temperature change. |
Target Area |
Penis |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | QWW |
Premarket Review |
Reproductive, Gynecology and Urology Devices
(DHT3B)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(k)
|
Regulation Number |
876.5021
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |