FDA product code QRC: Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
QRC is the FDA product code for non-implanted electrical stimulation device for management of premature ejaculation. It is a Class II device, regulated under 21 CFR 876.5026 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under QRC, 3 in the last five years, from 2 different applicants. The average 510(k) review took 198 days (median 215); 222 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation |
| Device class | Class II |
| Regulation | 21 CFR 876.5026 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QRC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 150 |
| 2025 | 1 | 228 |
| 2026 | 1 | 215 |
Compare with all 510(k) review times · Search every QRC clearance
Top QRC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Virility Medical , Ltd. | 2 | 2026-04-06 |
| Morari, Inc. | 1 | 2025-02-11 |
Most recent QRC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252809 | Virility Medical , Ltd. | in2 Smart (in2S) | 2026-04-06 | 215 |
| K241897 | Morari, Inc. | MOR | 2025-02-11 | 228 |
| K223595 | Virility Medical , Ltd. | vPATCH | 2023-05-01 | 150 |
Recalls for QRC devices
openFDA lists no recalls for product code QRC.
Frequently asked questions
What is FDA product code QRC?
QRC is the FDA product code for non-implanted electrical stimulation device for management of premature ejaculation. It is a Class II device, regulated under 21 CFR 876.5026 and reviewed by the Gastroenterology and Urology panel.
What device class is QRC?
Class II, regulation 21 CFR 876.5026. Typical premarket route: 510(k).
How long does a 510(k) take for product code QRC?
Across 3 cleared submissions the average was 198 days from receipt to decision (median 215).
Which companies have the most QRC clearances?
Virility Medical , Ltd. (2); Morari, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QRC
- Run a recall and safety report across every QRC manufacturer
- Watch product code QRC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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