FDA Product Code QWW: Non-medicated Topical Formulation For Treatment Of Erectile Dysfunction.
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.
Leading manufacturers include Futura Medical Developments Limited.
1
Total
0
Cleared
231d
Avg days
2023
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Non-medicated Topical Formulation For Treatment Of Erectile Dysfunction. Devices (Product Code QWW)
1 devices
About Product Code QWW - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QWW since 2023, with 0 receiving FDA clearance (average review time: 231 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.