ELITONE Urge Urinary Incontinence Device
FDA 510(k)Class II (US FDA 510(k))
by Elidah, Inc.
Identifiers
- 510(k) Number
- K223884 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)
The ELITONE Urge Urinary Incontinence Device is a cutaneous electrode stimulator for urinary incontinence, classified as a Class II medical device. It is intended for use in the treatment of overactive bladder and urge urinary incontinence in women.
The device is supplied sterile and is intended for single-use. It is MRI safe and is regulated under FDA 510(k) clearance. The device is available in specific sizes and should be stored according to the manufacturer's instructions.
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: Elitone® Urge | Overactive Bladder Treatment at Home, Elitone URGE Treatment - Elitone by Elidah, Elitone® | FDA-Cleared At-Home Bladder Control Treatments, ELITONE Urge Urinary Incontinence Device (K223884) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223884 | Class II | Active |
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Manufacturer
- Manufacturer
- Elidah, Inc.
Sources (1)
- FDA 510(k) K223884 24 fields · synced Sep 21, 2026