510(k) K252809
- Device
- in2 Smart (in2S)
- Applicant
- Virility Medical , Ltd.
- 510(k) number
- K252809
- Product code
- QRC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-06
- Date received
- 2025-09-03
- Regulation
- 876.5026
- Classification name
- Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Natalie Shukrun
- Address
- 24 Ha-Nagar St. Hod Hasharon IL 4527713 4527713
FDA Registration Numbers
- 3017709633
- 3020659203