# ITH: Equipment, Traction, Powered

- Device class: 2; regulation: 21 CFR 890.5900; FDA's rule: 510(k) required
- FDA decisions: 71
- 510(k) review time 2021–2025: median 233 days (middle half 229–373)
- Recalls: 2 (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)
- 2008: 4
- 2009: 1
- 2010: 1
- 2011: 1
- 2012: 1
- 2014: 2
- 2015: 2
- 2023: 1
- 2024: 1
- 2025: 2

## Most-cited predicates
- K981822: DRS System (1998), cited by 8
- K951622: Vax-D Therapeutic Table (1996), cited by 8
- K001712: 3D Activetrac (2000), cited by 7
- K053223: Triton/Tru-Trac/TX/Triton DTS Traction (2006), cited by 7
- K844385: Escotek Est Trac 401 (1985), cited by 6
- K053503: Vax-D Genesis System (Therapeutic Table) (2005), cited by 4
- K023160: DRX5000 (2002), cited by 4
- K051938: Triton/Tru-Trac/TX Traction Devices (2005), cited by 3
- K060735: DRX9000 True Spinal Decompression System (2006), cited by 3
- K993919: Dynatron 900 (2000), cited by 2

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