# BWK: Stimulator, Electro-Acupuncture

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 24
- 510(k) review time 2021–2025: median 209 days (middle half 81–331)
- 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)
- 2010: 2
- 2013: 2
- 2014: 3
- 2015: 1
- 2016: 1
- 2017: 1
- 2021: 2
- 2022: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K081943: Model ES-130 (2008), cited by 4
- K050123: P-Stim System (2006), cited by 2
- K051197: Aculife, Model SMW-01 (2006), cited by 2
- K202861: Needle Stimulator (2021), cited by 2
- K014273: Acustim (2002), cited by 2
- K130768: Jiajian CMN Stimulator (2013), cited by 1
- K140788: P-STIM (2014), cited by 1
- K840983: Pulselife Stimulator (1984), cited by 1

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