# ILX: Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

- Device class: 2; regulation: 21 CFR 890.5290; FDA's rule: 510(k) required
- FDA decisions: 15
- 510(k) review time 2021–2025: median 216 days (middle half 216–216)
- 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)
- 2002: 1
- 2007: 1
- 2008: 1
- 2009: 2
- 2010: 1
- 2012: 1
- 2013: 2
- 2019: 1
- 2020: 1
- 2024: 1

## Most-cited predicates
- K070541: Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino II (2008), cited by 5
- K903675: Magnetic Resonance Therapy Device (1991), cited by 3
- K022404: Actiband (2002), cited by 2
- K092044: Orthocor Knee System, Median, Large, X-Large (2009), cited by 2
- K202337: Pulsed electromagnetic field wrap (2020), cited by 1
- K091791: Provant System, Model 4201 (2010), cited by 1
- K121702: Orthocor Active Device Orthocor General Use Active Device (2013), cited by 1
- K091996: Orthocor Knee System Basic (2009), cited by 1

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