# LOF: Stimulator, Bone Growth, Non-Invasive

- Device class: 2; regulation: 21 CFR 890.5870; FDA's rule: 510(k) required
- FDA decisions: 12
- 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)
- 2017: 5
- 2018: 10
- 2019: 8
- 2020: 3
- 2021: 2
- 2022: 7
- 2023: 5
- 2024: 5
- 2025: 2
- 2026: 3

## Most-cited predicates
- P910066: Orthologic (TM)1000 Bone Growth Stimulator (1994), cited by 1

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