Product Code: QRC FDA class 2 21 CFR 876.5026

Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

Gastroenterology, Urology

The Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation is intended to treat premature ejaculation by delivering electrical stimulation to the perineal muscles and nerves in male patients. It is externally applied and does not involve any surgical implantation. Classified as FDA Class 2 under regulation 876.5026, it requires 510(k) clearance and falls under the Gastroenterology and Urology medical specialty. The device carries no implant or life-sustaining flags.

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510(k)s

FEI Numbers

Registration Numbers

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Years Active

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Basic Information

Product Code: QRC
Device Class: FDA class 2
Regulation Number: 876.5026
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

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Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 4 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252809	in2 Smart (in2S)	Apr 06, 2026	Substantially Equivalent	Virility Medical , Ltd.
K241897	MOR	Feb 11, 2025	Substantially Equivalent	Morari, Inc.
K223595	vPATCH	May 01, 2023	Substantially Equivalent	Virility Medical , Ltd.
DEN210012	vPatch	Nov 23, 2021	Unknown	Virility Medical