Device |
non-implanted electrical stimulation device for management of premature ejaculation |
Regulation Description |
Non-implanted electrical stimulation device for management of premature ejaculation. |
Definition |
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. |
Physical State |
Electrode(s) designed to stimulate perineal muscles and nerves. |
Technical Method |
Electrical stimulation of perineal muscles and nerves. |
Target Area |
Perineal muscles and nerves. |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | QRC |
Premarket Review |
Reproductive, Gynecology and Urology Devices
(DHT3B)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(k)
|
Regulation Number |
876.5026
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |