510(k) K223595
- Device
- vPATCH
- Applicant
- Virility Medical , Ltd.
- 510(k) number
- K223595
- Product code
- QRC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-01
- Date received
- 2022-12-02
- 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
- No
Applicant Contact#
- Contact
- Tal Golan
- Address
- 24 Hanagar St., Suite 106 Hod-Hasharon IL 4527713 4527713
FDA Registration Numbers#
- 3017709633
- 3020659203