# IPF: Stimulator, Muscle, Powered

- Device class: 2; regulation: 21 CFR 890.5850; FDA's rule: 510(k) required
- FDA decisions: 548
- 510(k) review time 2021–2025: median 169 days (middle half 91–270)
- Recalls: 6 (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)
- 2017: 5
- 2018: 5
- 2019: 4
- 2020: 9
- 2021: 15
- 2022: 7
- 2023: 9
- 2024: 7
- 2025: 3
- 2026: 3

## Most-cited predicates
- K021100: 300 PV Complete Electrotherapy System (2002), cited by 10
- K080950: Stiwell MED4 (2009), cited by 8
- K160992: HPM-6000 (2016), cited by 5
- K952273: Handmaster NMS1 (1996), cited by 4
- K010749: Electro Neuromuscular Stimulator, Model NMS-Digital (2001), cited by 4
- K972997: AM800 Automove Emg Triggered Electrical Muscle Stimulation (1997), cited by 4
- K020750: Digital Electrical Muscle Stimulator, Model EV-807 Digital Ems (2002), cited by 4
- K083105: Kneehab XP Conductive Garment, Type 411 (2009), cited by 4
- K050046: Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110S (2005), cited by 4
- K023347: Vital Stim (2002), cited by 4

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