# NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

- Device class: 2; regulation: 21 CFR 882.5890; FDA's rule: 510(k) required
- FDA decisions: 231
- 510(k) review time 2021–2025: median 123 days (middle half 90–185)
- 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)
- 2017: 17
- 2018: 16
- 2019: 19
- 2020: 14
- 2021: 14
- 2022: 20
- 2023: 15
- 2024: 20
- 2025: 15
- 2026: 5

## Most-cited predicates
- K133929: Health Expert Elctronic Stimulator (2014), cited by 15
- K060846: Therapeutic Massage Companion (2007), cited by 11
- K171803: HIVOX OTC Electrical Stimulator (2017), cited by 11
- K102598: HI-Dow-XP (2011), cited by 9
- K122744: Prospera Otc Tens Electronic Pulse Massager (2013), cited by 8
- K033122: 5000Z System (Otc) (2004), cited by 7
- K151035: PulseRelief (2015), cited by 7
- K130802: Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060) (2013), cited by 7
- K162517: Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 (2017), cited by 7
- K110068: Model PM3030 (2011), cited by 6

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