# GZI: Stimulator, Neuromuscular, External Functional

- Device class: 2; regulation: 21 CFR 882.5810; FDA's rule: 510(k) required
- FDA decisions: 61
- 510(k) review time 2021–2025: median 249 days (middle half 133–268)
- Recalls: 1 (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)
- 2016: 1
- 2017: 6
- 2018: 2
- 2019: 2
- 2020: 2
- 2021: 1
- 2022: 4
- 2023: 1
- 2024: 2
- 2025: 2

## Most-cited predicates
- K090750: RT300-SL, Model FA100052; RT300-Slsa, Model FA104581 (2009), cited by 4
- K974514: External Functional Neuromuscular Stimulator (1998), cited by 3
- K050991: The Odfs Dropped Foot Stimulator (2005), cited by 3
- K103343: L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left) (2011), cited by 3
- K123636: H200 Wireless Hand Rehabilitation System with Optional Intelli-Connect Earpiece Triggering Device (2013), cited by 3
- K123972: Walkaide System (2013), cited by 3
- K190285: L300 Go System (2019), cited by 3
- K052329: Walkaide System, Models 20-0100, 20-0310, 20-1000 (2005), cited by 2
- K060032: RT300-S, Model FA100052; RT300-SP, Model FA100053 (2006), cited by 2
- K073237: Rehastim & Rehamove (2007), cited by 2

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