# IMJ: Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

- Device class: 2; regulation: 21 CFR 890.5290; FDA's rule: 510(k) required
- FDA decisions: 45
- 510(k) review time 2021–2025: median 268 days (middle half 219–268)
- 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)
- 2004: 1
- 2009: 1
- 2012: 1
- 2014: 3
- 2016: 3
- 2018: 1
- 2019: 1
- 2023: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K083433: Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601 (2009), cited by 4
- K042554: Auto Therm 390, Model ME 390 (2004), cited by 3
- K022458: Auto*Therm 395, Model ME 395 (2002), cited by 2
- K973732: Megapulse II (1998), cited by 2
- K173300: ViaTherm BOOST (2018), cited by 2
- K861248: Curapuls 419 Diathermy Unit (1986), cited by 1
- K862589: Ultratherm 808 I (1986), cited by 1
- K182363: BTL-703 (2019), cited by 1
- K120093: BTL Elite (2012), cited by 1
- K161862: ThermoPro (2016), cited by 1

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