Product code QRC

Device name

Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.5026

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset