# QAJ: Cutaneous Electrode Stimulator For Urinary Incontinence

- Device class: 2; regulation: 21 CFR 876.5330; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 59 days (middle half 59–59)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2018: 1
- 2019: 1
- 2020: 1
- 2023: 1
- 2026: 1

## Most-cited predicates
- K183585: Elitone Device (2019), cited by 2
- DEN170049: Innovo (2018), cited by 2

Source page: https://510kreport.com/product-code/QAJ
Data by year (CSV): https://510kreport.com/product-code/QAJ.csv