# PFW: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

- Device class: 2; regulation: 21 CFR 890.5300; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 153 days (middle half 79–224)
- 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)
- 2008: 2
- 2013: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 2
- 2026: 1

## Most-cited predicates
- K191568: sam 2.0 Long Duration Ultrasound System (2020), cited by 4
- K211513: sam X1 Long Duration Ultrasound Device (2021), cited by 1
- K223019: sam 2.0 Long Ultrasound Device (2023), cited by 1
- K081075: Painshield MD (2008), cited by 1
- K072256: HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with Optional Hands-Free Operation, Model (2008), cited by 1
- K130978: ZTX Ultrasonic Diathermy Device (2013), cited by 1

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