DeviceClearance

Product code QAJ— Gastroenterology, Urology

ELITONE Urge Urinary Incontinence Device

Classification name
Cutaneous Electrode Stimulator For Urinary Incontinence
Device class
Class 2
Regulation
21 CFR 876.5330
Advisory panel
Gastroenterology, Urology
Total cleared
5
First cleared
Most recent

FDA classification definition

“A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.”

— U.S. Food and Drug Administration, device classification record for product code QAJ under 21 CFR 876.5330, via openFDA

Market context for product code QAJ

FDA has cleared 5 devices under product code QAJ between 2018 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QAJ

Recent clearances under product code QAJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.