QAJ — Cutaneous Electrode Stimulator For Urinary Incontinence Class II
Classification Details
- Product Code
- QAJ
- Device Class
- Class II
- Regulation Number
- 876.5330
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253285 | elidah | Elitone for Men | January 23, 2026 |
| K223884 | elidah | ELITONE Urge Urinary Incontinence Device | February 24, 2023 |
| K192357 | atlantic therapeutics | INNOVO | January 16, 2020 |
| K183585 | elidah | Elitone Device | February 11, 2019 |
| DEN170049 | bio-medical research | Innovo | November 6, 2018 |