QAJ
5 FDA 510(k) clearances · Product code
116 daysmedian time to decision
414 days90th percentile
5clearances measured
FDA profile
- Official device name
- Cutaneous Electrode Stimulator For Urinary Incontinence
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5330
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Elitone for Men (K253285) | Elidah, Inc. | 2026-01-23 |
| ELITONE Urge Urinary Incontinence Device (K223884) | Elidah, Inc. | 2023-02-24 |
| INNOVO (K192357) | Atlantic Therapeutics, Ltd. | 2020-01-16 |
| Elitone Device (K183585) | Elidah, Inc. | 2019-02-11 |
| Innovo (DEN170049) | Bio-Medical Research, Ltd. | 2018-11-06 |
Track QAJ automatically
Every clearance here is in the API, with alerts when new ones post.