# IMA: Pack, Heat, Moist

- Device class: 1; regulation: 21 CFR 890.5730; FDA's rule: 510(k) exempt
- FDA decisions: 8
- Recalls: 0 (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)
- 1979: 2
- 1980: 1
- 1982: 1
- 1983: 1
- 1984: 1
- 1995: 1
- 2015: 1

## Most-cited predicates
- K832803: Steam Pak Moist Heat (1983), cited by 1
- K841698: Heat Pack (1984), cited by 1

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