QRC

Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

Product code

QRC

Device name

Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

Device class

Class 2

21 CFR

21 CFR 876.5026

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-04-06.

2 summaries are archived here for direct download.