QAJ

Cutaneous Electrode Stimulator For Urinary Incontinence

Product code
QAJ
Device name
Cutaneous Electrode Stimulator For Urinary Incontinence
Device class
Class 2
21 CFR
21 CFR 876.5330
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
5 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-01-23.

NumberDecision dateApplicantDevice nameSummary
K2532852026-01-23Elidah, Inc.Elitone for MenPDF

1 summaries are archived here for direct download.

Official FDA classification page: QAJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).