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.