Cleared Traditional

K223884 - ELITONE Urge Urinary Incontinence Device (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K223884 · Elidah, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
59d
Days
Class 2
Risk

K223884 is an FDA 510(k) clearance for the ELITONE Urge Urinary Incontinence Device. Classified as Cutaneous Electrode Stimulator For Urinary Incontinence (product code QAJ), Class II - Special Controls.

Submitted by Elidah, Inc. (Monroe, US). The FDA issued a Cleared decision on February 24, 2023 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5330 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Elidah, Inc. devices

Submission Details

510(k) Number K223884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2022
Decision Date February 24, 2023
Days to Decision 59 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 130d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QAJ Cutaneous Electrode Stimulator For Urinary Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5330
Definition A Transcutaneous Electrical Continence Device Consists Of Cutaneous Electrodes That Are Used To Apply External Stimulation To Reduce Urinary Incontinence.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04752709 Completed Interventional Industry-sponsored

Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women

Clinical Study to Evaluate the Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women

82
Patients (actual)
1
Site
Treatment
Purpose
Quadruple
Masking
Condition studied Urge Incontinence
Study design Parallel
Eligibility Female only · 21 Years+
Principal investigator Gloria Kolb, M.S.
Sponsor Elidah, Inc. (industry)
Started 2020-11-19 → Primary completion 2021-05-30 → Completed 2021-09-30
Primary outcome
Change in Average Number of Urinary Incontinence Episodes Per Day
Secondary outcome
Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL)
View full study on ClinicalTrials.gov