# ISD: Exerciser, Measuring

- Device class: 2; regulation: 21 CFR 890.5360; FDA's rule: 510(k) exempt
- FDA decisions: 61
- Recalls: 1 (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)
- 1994: 8
- 1995: 1
- 1996: 2
- 1999: 2
- 2006: 1
- 2008: 1
- 2012: 1
- 2015: 1
- 2019: 1
- 2020: 1

## Most-cited predicates
- K080545: Actitrainer (2008), cited by 5
- K851097: Lode Model Corival Ergometer (1985), cited by 2
- K053078: Ergoselect 100 K/P, Ergoselect 200 K/P (2006), cited by 1

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