510(k) K241897
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 2025
- Date Received
- June 28, 2024
- 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.