# BXB: Exerciser, Powered

- Device class: 1; regulation: 21 CFR 890.5380; FDA's rule: 510(k) exempt
- FDA decisions: 160
- Recalls: 3 (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)
- 1989: 9
- 1990: 9
- 1991: 11
- 1992: 13
- 1993: 12
- 1994: 21
- 1995: 16
- 1996: 2
- 2001: 1
- 2008: 1

## Most-cited predicates

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