510(k) K252809
K252809 is an FDA 510(k) premarket notification submitted by Virility Medical , Ltd. for the device "in2 Smart (in2S)". The FDA issued a decision of Substantially Equivalent on Apr 6, 2026. 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 , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 6, 2026
- Date Received
- Sep 3, 2025
- Clearance Type
- Traditional
- 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.