Cutaneous Electrode Stimulator For Urinary Incontinence
The Cutaneous Electrode Stimulator for Urinary Incontinence is a transcutaneous electrical continence device consisting of cutaneous electrodes that apply external electrical stimulation to reduce urinary incontinence, used as a non-invasive neuromodulation treatment. It is classified as a Class 2 device under regulation 876.5330, requiring 510(k) premarket notification, and falls within the Gastroenterology/Urology (GU) medical specialty. The product code is QAJ. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QAJ
- Device Class
- FDA class 2
- Regulation Number
- 876.5330
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253285 | Elitone for Men | Jan 23, 2026 | Substantially Equivalent | Elidah, Inc. |
| K223884 | ELITONE Urge Urinary Incontinence Device | Feb 24, 2023 | Substantially Equivalent | Elidah, Inc. |
| K192357 | INNOVO | Jan 16, 2020 | Substantially Equivalent | Atlantic Therapeutics, Ltd. |
| K183585 | Elitone Device | Feb 11, 2019 | Substantially Equivalent | Elidah, Inc. |
| DEN170049 | Innovo | Nov 06, 2018 | Unknown | Bio-Medical Research, Ltd. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.