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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 the device name listed in this FDA 510(k) record. The listed applicant is Elidah, Inc.. It received FDA 510(k) clearance on 2023-02-24 under 510(k) 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. The listed applicant is Elidah, Inc.. The 510(k) number is K223884.

When did ELITONE Urge Urinary Incontinence Device receive FDA 510(k) clearance?

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

Who is the listed applicant for ELITONE Urge Urinary Incontinence Device?

The FDA 510(k) record lists Elidah, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06161506Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate CancerRECRUITINGNCT06217328RESTORE: An RCT to Evaluate the Efficacy of the Revi SystemACTIVE_NOT_RECRUITINGNCT07206446A Prospective Evaluation of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women: The RiSolve TrialCOMPLETEDNCT07300904Tensi+ for Treating Overactive BladderNOT_YET_RECRUITINGNCT07536139COMPARATIVE EFFICACY OF ELECTROMAGNETIC FIELD THERAPY AND TIBIAL NERVE STIMULATION IN URGE URINARY INCONTINENCENOT_YET_RECRUITINGNCT07635251A Novel Wearable Transcutaneous Tibial Nerve Stimulation (TTNS) Device in the Treatment of Patients With Overactive Bladder (OAB) and NocturiaNOT_YET_RECRUITING

Other records listing Elidah, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253285Elitone for MenK183585Elitone Device

Related Devices (Code: QAJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253285Elitone for MenElidah, Inc.K192357INNOVOAtlantic Therapeutics, Ltd.K183585Elitone DeviceElidah, 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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