QRC — Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation Class II

FDA Device Classification

Classification Details

Product Code
QRC
Device Class
Class II
Regulation Number
876.5026
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252809virility medicalin2 Smart (in2S)April 6, 2026
K241897morariMORFebruary 11, 2025
K223595virility medicalvPATCHMay 1, 2023
DEN210012virility medicalvPatchNovember 23, 2021