QAJ — Cutaneous Electrode Stimulator For Urinary Incontinence Class II
FDA product code QAJ covers "Cutaneous Electrode Stimulator For Urinary Incontinence", a Class II medical device regulated under 21 CFR 876.5330. Submissions are reviewed by the Gastroenterology, Urology panel. At least 5 recent 510(k) clearances have been granted under this product code.
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.