FDA Product Code QAJ: Cutaneous Electrode Stimulator For Urinary Incontinence
A Transcutaneous Electrical Continence Device Consists Of Cutaneous Electrodes That Are Used To Apply External Stimulation To Reduce Urinary Incontinence.
Leading manufacturers include Elidah, Inc., Bio-Medical Research, Ltd. and Atlantic Therapeutics, Ltd..
5
Total
4
Cleared
156d
Avg days
2018
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
116d
recently vs 166d historically
FDA 510(k) Cleared Cutaneous Electrode Stimulator For Urinary Incontinence Devices (Product Code QAJ)
5 devices
Cleared
Jan 23, 2026
Elitone for Men
Elidah, Inc.
Gastroenterology & Urology
116d
Cleared
Feb 24, 2023
ELITONE Urge Urinary Incontinence Device
Elidah, Inc.
Gastroenterology & Urology
59d
Cleared
Jan 16, 2020
INNOVO
Atlantic Therapeutics, Ltd.
Gastroenterology & Urology
140d
Cleared
Feb 11, 2019
Elitone Device
Elidah, Inc.
Gastroenterology & Urology
52d
Not Cleared
Nov 06, 2018
Innovo
Bio-Medical Research, Ltd.
Gastroenterology & Urology
414d
About Product Code QAJ - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code QAJ since 2018, with 4 receiving FDA clearance (average review time: 156 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - QAJ Product Code
Recent submissions under QAJ have taken an average of 116 days to reach a decision - down from 166 days historically, suggesting improved FDA processing for this classification.
QAJ devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →