510(k) DEN210012

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

November 23, 2021

Date Received

March 30, 2021

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

Device Class

Class II

Regulation Number

876.5026

Review Panel

GU

Submission Type

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.