FDA 510(k)

Elitone for Men

K-Number: K253285 · 2026-01-23

Decision Date2026-01-23

Product CodeQAJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Elitone for Men is the device name listed in this FDA 510(k) record. The listed applicant is Elidah, Inc.. It received FDA 510(k) clearance on 2026-01-23 under 510(k) number K253285. 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 for Men?

Elitone for Men is a medical device that received FDA 510(k) clearance on 2026-01-23. The listed applicant is Elidah, Inc.. The 510(k) number is K253285.

When did Elitone for Men receive FDA 510(k) clearance?

Elitone for Men received FDA 510(k) clearance on 2026-01-23, under 510(k) number K253285.

Who is the listed applicant for Elitone for Men?

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 for Men?

The FDA product code for Elitone for Men is QAJ.

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.

K223884ELITONE Urge Urinary Incontinence Device K183585Elitone Device

Related Devices (Code: QAJ)

K223884ELITONE Urge Urinary Incontinence DeviceElidah, Inc.K192357INNOVOAtlantic Therapeutics, Ltd.K183585Elitone DeviceElidah, Inc.

Official Source

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