FDA Product Code QRC: Non-implanted Electrical Stimulation Device For Management Of Premature Ejaculation
A Non-implanted Electrical Stimulation Device For Management Of Premature Ejaculation Is Intended To Be Used In Patients With Premature Ejaculation By Delivery Of Electrical Stimulation To The Perineal Muscles And Nerves.
Leading manufacturers include Virility Medical , Ltd., Virility Medical and Morari, Inc..
FDA 510(k) Cleared Non-implanted Electrical Stimulation Device For Management Of Premature Ejaculation Devices (Product Code QRC)
About Product Code QRC - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QRC since 2021, with 3 receiving FDA clearance (average review time: 208 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for QRC submissions have been consistent, averaging 222 days recently vs 194 days historically.
QRC devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →