# IMI: Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

- Device class: 2; regulation: 21 CFR 890.5300; FDA's rule: 510(k) required
- FDA decisions: 89
- 510(k) review time 2021–2025: median 439 days (middle half 244–448)
- Recalls: 3 (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)
- 2012: 1
- 2013: 1
- 2014: 2
- 2015: 1
- 2016: 3
- 2017: 1
- 2021: 1
- 2022: 1
- 2023: 2
- 2025: 1

## Most-cited predicates
- K031329: Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional Accessory) (2003), cited by 7
- K024307: Dermosonic Non-Invasive Subdermal Therapy System (2003), cited by 5
- K013192: Sonicator Plus 930, Model ME 930 (2001), cited by 4
- K091615: Med Contour (2010), cited by 2
- K202788: Sonomed IV, Sonomed V (2021), cited by 1
- K230472: Sonopuls 190 (2023), cited by 1
- K050410: Hes Ultrasonic Therapy Appliance, Models HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ) (2005), cited by 1
- K923076: Ultra SX (1993), cited by 1
- K130888: Sonopulse/ Sonopulse Iii (2014), cited by 1
- K222098: ManaSport+ (2023), cited by 1

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