510(k) K223595

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

May 1, 2023

Date Received

December 2, 2022

Clearance Type

Traditional

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.