# NYN: Stimulator, Electrical, Transcutaneous, For Arthritis

- Device class: 2; regulation: 21 CFR 882.5890; FDA's rule: 510(k) required
- FDA decisions: 8
- 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)
- 1997: 1
- 1999: 1
- 2003: 1
- 2005: 1
- 2007: 1
- 2008: 1
- 2011: 1
- 2015: 1

## Most-cited predicates
- K030332: Modification to Bionicare Stimulator System, Model Bio-1000 (2003), cited by 5
- K971437: Bionicare Stimulator System. Model Bio-1000 (1997), cited by 4
- K983228: Bionicare Stimilator System, Model Bio-1000 (1999), cited by 2
- K052625: Bionicare Stimulator System, Model Bio-1000 (2005), cited by 2
- K073386: Joint Stim, Model 1000 (2008), cited by 1

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