# DEN170049: Innovo

- Pathway: De Novo (Direct)
- Applicant: Bio-Medical Research, Ltd.
- Decided: Nov 6, 2018 after 414 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K183585: Elitone Device (2019), 2 descendants of its own
- K253285: Elitone for Men (2026), 0 descendants of its own
- K223884: ELITONE Urge Urinary Incontinence Device (2023), 0 descendants of its own
- K192357: Innovo (2020), 0 descendants of its own

## Indications for use
The Innovo is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females. The Innovo is indicated for prescription use only.

Source page: https://510kreport.com/device/DEN170049
Methodology: https://510kreport.com/methodology