Skip to contentDe Novo DEN210012
- Device
- vPatch
- Contact
- bosmat friedman
- De Novo number
- DEN210012
- Product code
- QRC
- Regulation
- 876.5026
- Classification name
- non-implanted electrical stimulation device for management of premature ejaculation
- Decision
- granted (DENG)
- Decision date
- 2021-11-23
- Date received
- 2021-03-30
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QRC
- Device name
- Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.5026
- Implant
- N
- Life sustain/support
- N