Device class
Class II
Regulation 876.5305
Total clearances
4
2023-08-16 → 2026-07-28
Definition
What is Implanted Tibial Electrical Urinary Continence Device
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 details
Medical specialty
Gastroenterology, Urology
Regulation number
876.5305
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 64566 |
CPT
|
— |
High
|
Posterior tibial nerve neurostimulation for urinary dysfunction; standard CPT for tibial neuromodulation |
Pulse
Most recent 510(k) clearances