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..
FDA 510(k) Cleared Cutaneous Electrode Stimulator For Urinary Incontinence Devices (Product Code QAJ)
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 Review Time
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 →