# IMG: Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

- Device class: 2; regulation: 21 CFR 890.5860; FDA's rule: 510(k) required
- FDA decisions: 55
- 510(k) review time 2021–2025: median 281 days (middle half 281–281)
- 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)
- 2003: 3
- 2004: 2
- 2005: 1
- 2007: 3
- 2010: 1
- 2011: 3
- 2012: 2
- 2015: 2
- 2016: 1
- 2025: 1

## Most-cited predicates
- K031077: Vectra Epr System and Intelect Epr System (2003), cited by 9
- K071137: Sonicator Plus 940, Model ME940 (2007), cited by 4
- K982317: Vectra Combo (1999), cited by 3
- K001166: Ultra V Therapeutic Ultrasound (2000), cited by 2
- K935728: Dynatron 150 (1994), cited by 2
- K052340: DU857 Dual Frequency Ultrasound Therapy  and Muscle Stimulator System (2005), cited by 2
- K934846: Sonicator 716 (1994), cited by 1
- K121059: Soleoline, Soleo Stim, Soleo Sono, Soleo Sonostim (2012), cited by 1
- K120217: Sonicstimu Combo Therapeutic Device (2012), cited by 1
- K102190: Winstim (2011), cited by 1

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