QAJ
- Product code
- QAJ
- Device name
- Cutaneous Electrode Stimulator For Urinary Incontinence
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5330
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 5 (all years; only the last 3 years are listed here)
FDA classification definition
A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253285 | 2026-01-23 | Elidah, Inc. | Elitone for Men |
Official FDA classification page: QAJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).