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Elitone for Men

FDA 510(k)

Class II (US FDA 510(k))

510(k) K253285

by Elidah, Inc.

Identifiers

510(k) Number
K253285 FDA 510(k)
FDA Product Code
QAJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5330 FDA 510(k)
Regulation Number
876.5330 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Elitone for Men is a Cutaneous Electrode Stimulator For Urinary Incontinence. It is a non-invasive, at-home treatment designed to help men regain bladder control after prostate surgery.

The device is supplied for over-the-counter use and is intended for use in a home setting. It is classified as a Class II medical device under regulation number 876.5330 with product code QAJ and has received FDA 510(k) clearance (K253285).

Frequently asked questions

What is Elitone for Men used for?

Elitone for Men is a cutaneous electrode stimulator designed to help men regain bladder control after prostate surgery. It delivers non-invasive electrical stimulation to the pelvic floor muscles to support urinary incontinence treatment in a home setting.

How is Elitone for Men supplied and where is it intended to be used?

Elitone for Men is supplied for over-the-counter use and is intended for use in a home setting. It is designed as a non-invasive, at-home treatment device for men managing urinary incontinence following prostate surgery.

Is Elitone for Men a single-use or reusable device?

Elitone for Men is a reusable device intended for repeated use in a home setting. As a cutaneous electrode stimulator, it is designed for ongoing, non-invasive treatment sessions to support bladder control rehabilitation over time.

What regulatory pathway was used for Elitone for Men?

Elitone for Men received FDA 510(k) clearance under submission number K253285. It was determined to be substantially equivalent to a predicate device and cleared as a Class II medical device under regulation number 876.5330 with product code QAJ.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: New FDA-Cleared At-Home Treatment Helps Men Regain Bladder Control ..., FDA-Cleared At-Home Treatment Helps Men After Prostate Surgery, New FDA-Cleared At-Home Treatment Helps Men Regain Bladder Control ..., New FDA-Cleared At-Home Treatment Helps Men Regain Bladder ... - BioSpace

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Elidah, Inc.

Sources (1)

  • FDA 510(k) K253285 24 fields · synced Sep 24, 2026