Implanted Tibial Electrical Urinary Continence Device
QXM is the FDA product code for Implanted Tibial Electrical Urinary Continence Device, a class II device type, regulated under 21 CFR 876.5305. FDA's definition for this code reads: "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...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QXM
- Device name
- Implanted Tibial Electrical Urinary Continence Device
- 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.
- Regulation
- 21 CFR 876.5305
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code QXM
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code QXM| Applicant | Clearances |
|---|---|
| Bluewind Medical Ltd. | 4 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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