# DEN210012: vPatch

- Pathway: De Novo (Direct)
- Applicant: Virility Medical
- Decided: Nov 23, 2021 after 238 days
- Product code: QRC (Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation)
- Device class: 2
- Regulation: 21 CFR 876.5026
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K223595: vPATCH (2023), 2 descendants of its own
- K252809: in2 Smart (in2S) (2026), 0 descendants of its own
- K241897: MOR (2025), 0 descendants of its own

## Indications for use
The vPatch is indicated for management of premature ejaculation in males who ejaculate after intromission. It is designed to increase the time between arousal and ejaculation by delivery of short duration, low-intensity electrical stimulation to the perineal muscles and nerves during intercourse.

Source page: https://510kreport.com/device/DEN210012
Methodology: https://510kreport.com/methodology