QXM — Implanted Tibial Electrical Urinary Continence Device Class II
Classification Details
- Product Code
- QXM
- Device Class
- Class II
- Regulation Number
- 876.5305
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Definition
An implanted tibial electrical urinary continence device is an implanted prescription device that receives power from a non-implanted external power source to provide electrical stimulation of the tibial nerve in proximity to the ankle. The device is intended for the treatment of overactive bladder related symptoms of urge urinary incontinence, urinary urgency, urinary frequency and nocturia.