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FDA 510(k)

ELITONE Urge Urinary Incontinence Device

K-Number: K223884 · 2023-02-24

ApplicantElidah, Inc.
Decision Date2023-02-24
Product CodeQAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ELITONE Urge Urinary Incontinence Device is a medical device manufactured by Elidah, Inc.. It received FDA 510(k) clearance on 2023-02-24 under approval number K223884. The device is classified under product code QAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELITONE Urge Urinary Incontinence Device?

ELITONE Urge Urinary Incontinence Device is a medical device that received FDA 510(k) clearance on 2023-02-24. It is manufactured by Elidah, Inc.. The 510(k) number is K223884.

When was ELITONE Urge Urinary Incontinence Device approved by the FDA?

ELITONE Urge Urinary Incontinence Device received FDA 510(k) clearance on 2023-02-24, under approval number K223884.

What company makes ELITONE Urge Urinary Incontinence Device?

ELITONE Urge Urinary Incontinence Device is manufactured by Elidah, Inc..

What is the FDA product code for ELITONE Urge Urinary Incontinence Device?

The FDA product code for ELITONE Urge Urinary Incontinence Device is QAJ.

Related Clinical Trials

NCT07534696 Evaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy ENROLLING_BY_INVITATION NCT04115605 A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence TERMINATED NCT06885931 Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications) RECRUITING NCT07583706 A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic Hyperplasia RECRUITING NCT06982235 Stone and Laser Therapies Post-Market Study (SALT) RECRUITING NCT04829994 Post-Market Clinical Follow-Up onTVT EXACT® Continence System ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41229180 What Is Required for AI to Improve the Assessment and Treatment of Patients With Lower Urinary Tract Dysfunction? ICI-RS 2025. Neurourology and urodynamics (2025)

Other Devices by Elidah, Inc.

K183585Elitone Device K253285Elitone for Men

Related Devices (Code: QAJ)

DEN170049InnovoBio-Medical Research, Ltd. K183585Elitone DeviceElidah, Inc. K192357INNOVOAtlantic Therapeutics, Ltd. K253285Elitone for MenElidah, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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