510(k) DEN210012
DEN210012 is an FDA 510(k) premarket notification submitted by Virility Medical for the device "vPatch". The FDA issued a decision of De Novo Granted on Nov 23, 2021. The device falls under product code QRC (Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation), a Class II device regulated under 21 CFR 876.5026. Virility Medical has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Nov 23, 2021
- Date Received
- Mar 30, 2021
- Clearance Type
- Direct
- 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.