# PHW: Cold Pack And Vibrating Massager

- Device class: 1; regulation: 21 CFR 890.5975; FDA's rule: 510(k) exempt
- FDA decisions: 2
- 510(k) review time 2021–2025: median 957 days (middle half 957–957)
- 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)
- 2014: 1
- 2023: 1

## Most-cited predicates
- K130631: BUZZY (2014), cited by 1

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