# K223884: ELITONE Urge Urinary Incontinence Device

- Pathway: 510(k) (Traditional)
- Applicant: Elidah, Inc.
- Decided: Feb 24, 2023 after 59 days
- Product code: QAJ (Cutaneous Electrode Stimulator For Urinary Incontinence)
- Device class: 2
- Regulation: 21 CFR 876.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN170049 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183585: Elitone Device, Elidah, Inc. (2019) Summary page 4.

## Indications for use
ELITONE Urge is a non-implanted muscle stimulator designed to treat urge urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding tissues.

Source page: https://510kreport.com/device/K223884
Methodology: https://510kreport.com/methodology