QRCClass II
Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
21 CFR 876.5026 / Gastroenterology, Urology
QRC is the FDA product code for Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation, a class II device type, regulated under 21 CFR 876.5026. FDA's definition for this code reads: "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". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QRC
- Device name
- Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
- FDA 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.
- Regulation
- 21 CFR 876.5026
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code QRC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code QRC| Applicant | Clearances |
|---|---|
| Virility Medical Ltd. | 3 |
| Morari, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.