21 CFR 876.5305 — Implanted Tibial Electrical Urinary Continence Device
Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5305
Identification
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.
Classification Rationale
Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks, and the risks can be mitigated by the use of general and the identified special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QXM | Implanted Tibial Electrical Urinary Continence Device | 2 | 3 | SaMD, Implant |
Special Controls
QXM — Implanted Tibial Electrical Urinary Continence Device
In combination with the general controls of the FD&C Act, an implanted tibial electrical urinary continence device is subject to the following special controls:
De Novo Order DEN220073
