DeviceClearance

Product code QRC— Gastroenterology, Urology

MOR

Classification name
Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
Device class
Class 2
Regulation
21 CFR 876.5026
Advisory panel
Gastroenterology, Urology
Total cleared
4
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QRC under 21 CFR 876.5026, via openFDA

Market context for product code QRC

FDA has cleared 4 devices under product code QRC between 2021 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QRC

Recent clearances under product code QRC

Data sourced from openFDA. This site is unofficial and independent of the FDA.