Device |
cutaneous electrode stimulator for urinary incontinence |
Regulation Description |
Transcutaneous electrical continence device. |
Definition |
A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence. |
Physical State |
Electrodes |
Technical Method |
Current applied to pelvic floor muscles to improve strength. |
Target Area |
Pelvic floor muscles |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | QAJ |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(k)
|
Regulation Number |
876.5330
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |