# NUW: Stimulator, Muscle, Powered, Dental

- Device class: 2; regulation: 21 CFR 890.5850; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 179 days (middle half 167–191)
- 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)
- 1977: 1
- 1984: 2
- 1989: 1
- 1990: 1
- 2003: 1
- 2004: 1
- 2021: 1
- 2025: 1

## Most-cited predicates
- K031998: Model J-5 Mvo-Monitor (2003), cited by 4
- K842223: J4 Myo-Monitor (1984), cited by 2
- K842224: BNS 40 (1984), cited by 1
- K203525: D function (2021), cited by 1

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