Panels › Gastroenterology, Urology › Product code QAJ · Class 2
Cutaneous Electrode Stimulator For Urinary Incontinence
Regulation 876.5330
1510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QAJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Elidah, Inc. | 3 | 0 |
| Atlantic Therapeutics, Ltd. | 1 | 0 |
| Bio-Medical Research, Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 23, 2026 | K253285 | Elitone for Men Elidah, Inc. | QAJ |
| Feb 24, 2023 | K223884 | ELITONE Urge Urinary Incontinence Device Elidah, Inc. | QAJ |
| Jan 16, 2020 | K192357 | INNOVO Atlantic Therapeutics, Ltd., IE | QAJ |
| Feb 11, 2019 | K183585 | Elitone Device Elidah, Inc. | QAJ |
| Nov 6, 2018 | DEN170049 | Innovo Bio-Medical Research, Ltd., IE | QAJ |
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