# QPL: Electromagnetic Stimulator, Pain Relief

- Device class: 2; regulation: 21 CFR 882.5890; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 172 days (middle half 154–222)
- 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)
- 2021: 1
- 2023: 1
- 2024: 1
- 2025: 3

## Most-cited predicates
- K230014: MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption (2023), cited by 3
- K210021: Axon Therapy (2021), cited by 2
- K233364: Axon Therapy (2024), cited by 1

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