Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.
The non-medicated topical formulation for treatment of erectile dysfunction (product code QWW) is a Class 2 device in the Gastroenterology/Urology specialty (regulation 876.5021) that is applied to the penis and stimulates nerve endings by inducing a temperature change to promote tumescence and erection. Requiring 510(k) clearance, the device uses a non-pharmacological mechanism of action via thermal stimulation. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QWW
- Device Class
- FDA class 2
- Regulation Number
- 876.5021
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
A non-medicated topical formulation for treatment of erectile dysfunction is a device that is applied on the penis and stimulates the nerve endings by inducing a temperature change, leading to tumescence and erection.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN220078 | Eroxon | Jun 09, 2023 | Unknown | Futura Medical Developments Limited |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.