# GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

- Device class: 2; regulation: 21 CFR 882.5890; FDA's rule: 510(k) required
- FDA decisions: 606
- 510(k) review time 2021–2025: median 166 days (middle half 80–263)
- Recalls: 7 (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: 3
- 2018: 2
- 2019: 3
- 2020: 4
- 2021: 3
- 2022: 4
- 2023: 1
- 2024: 3
- 2025: 1
- 2026: 2

## Most-cited predicates
- K061650: Select Tens, Model 4600S (2007), cited by 7
- K042912: INTERX5000 (2005), cited by 7
- K951951: Focus Model 795 Unit (1996), cited by 6
- K021755: Apex Medical Digital Tens TS1211, TS1212 (2002), cited by 6
- K970203: Epix VT (1997), cited by 5
- K002874: Well-Tens (2001), cited by 4
- K994266: Fdtens 2010 (2000), cited by 4
- K982324: Vectra Pro Models 2 and 4 (1999), cited by 4
- K082011: Medistim XP, Type 281 and Meditens XP, Type 458 (2008), cited by 4
- K040512: Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A, WL-2203B and WL-2401 (2004), cited by 4

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