Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.

QWW · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5021

Classification

FDA Product Code: QWW
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.5021
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-medicated topical formulation for treatment of erectile dysfunction is a device that is applied on the penis and stimulates the nerve endings by inducing a temperature change, leading to tumescence and erection.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 5

Source

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