Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

QRC · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5026

Classification

FDA Product Code: QRC
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.5026
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown