QXM
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Implanted Tibial Electrical Urinary Continence Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5305
- Medical specialty
- Gastroenterology, Urology
- Flags
- Implant
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Revi System (K253651) | Bluewind Medical , Ltd. | 2026-07-28 |
| Revi System (K252391) | Bluewind Medical , Ltd. | 2025-12-12 |
| Revi™ System (K240037) | Bluewind Medical , Ltd. | 2024-05-02 |
| Revi System (DEN220073) | Bluewind Medical , Ltd. | 2023-08-16 |
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Every clearance here is in the API, with alerts when new ones post.