# NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

- Device class: 2; regulation: 21 CFR 890.5850; FDA's rule: 510(k) required
- FDA decisions: 163
- 510(k) review time 2021–2025: median 167 days (middle half 72–280)
- Recalls: 2 (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: 10
- 2018: 6
- 2019: 14
- 2020: 11
- 2021: 12
- 2022: 6
- 2023: 12
- 2024: 12
- 2025: 15
- 2026: 4

## Most-cited predicates
- K011880: Compex Sport (2002), cited by 12
- K083140: Compex Sport Plus (2009), cited by 9
- K010335: Slendertone Flex, Model, 512 (2001), cited by 9
- K133225: E-Fit EF-1280 Ems Machine (2014), cited by 7
- K030708: Slendertone Flex Abdominal Training System, Type 515 (2003), cited by 6
- K070142: Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20 (2007), cited by 6
- K180813: BTL 799-2 (2018), cited by 6
- K190456: BTL 799-2L (2019), cited by 5
- K092476: Sport-Elec Body Control System, Model 4M (2010), cited by 5
- K151834: BEMER Classic Set, BEMER Pro-Set (2017), cited by 5

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