# K183585: Elitone Device

- Pathway: 510(k) (Traditional)
- Applicant: Elidah, Inc.
- Decided: Feb 11, 2019 after 52 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: 1 generation back to DEN170049 (2018). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170049: Innovo, Bio-Medical Research, Ltd. (2018) Summary page 4.

## Most influential descendants
- K253285: Elitone for Men (2026), 0 descendants of its own
- K223884: ELITONE Urge Urinary Incontinence Device (2023), 0 descendants of its own

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

Source page: https://510kreport.com/device/K183585
Methodology: https://510kreport.com/methodology