FDA product code QAJ: Cutaneous Electrode Stimulator For Urinary Incontinence
QAJ is the FDA product code for cutaneous electrode stimulator for urinary incontinence. It is a Class II device, regulated under 21 CFR 876.5330 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under QAJ, 2 in the last five years, from 2 different applicants. The average 510(k) review took 92 days (median 88); 116 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.
Classification
| Field | Value |
|---|---|
| Device name | Cutaneous Electrode Stimulator For Urinary Incontinence |
| Device class | Class II |
| Regulation | 21 CFR 876.5330 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QAJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 52 |
| 2020 | 1 | 140 |
| 2023 | 1 | 59 |
| 2026 | 1 | 116 |
Compare with all 510(k) review times · Search every QAJ clearance
Top QAJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Elidah, Inc. | 3 | 2026-01-23 |
| Atlantic Therapeutics, Ltd. | 1 | 2020-01-16 |
Most recent QAJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253285 | Elidah, Inc. | Elitone for Men | 2026-01-23 | 116 |
| K223884 | Elidah, Inc. | ELITONE Urge Urinary Incontinence Device | 2023-02-24 | 59 |
| K192357 | Atlantic Therapeutics, Ltd. | INNOVO | 2020-01-16 | 140 |
| K183585 | Elidah, Inc. | Elitone Device | 2019-02-11 | 52 |
Recalls for QAJ devices
openFDA lists no recalls for product code QAJ.
Frequently asked questions
What is FDA product code QAJ?
QAJ is the FDA product code for cutaneous electrode stimulator for urinary incontinence. It is a Class II device, regulated under 21 CFR 876.5330 and reviewed by the Gastroenterology and Urology panel.
What device class is QAJ?
Class II, regulation 21 CFR 876.5330. Typical premarket route: 510(k).
How long does a 510(k) take for product code QAJ?
Across 4 cleared submissions the average was 92 days from receipt to decision (median 88).
Which companies have the most QAJ clearances?
Elidah, Inc. (3); Atlantic Therapeutics, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QAJ
- Run a recall and safety report across every QAJ manufacturer
- Watch product code QAJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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