# NTU: Evoked Potential Stimulator, Thermal

- Device class: 2; regulation: 21 CFR 882.1870; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 2005: 2
- 2006: 1

## Most-cited predicates
- K051448: Modified Contact-Heat Evoked Potential Stimulator (Cheps) (2005), cited by 1
- K041908: Contact Heat-Evoked Potential Stimulator (Cheps) (2005), cited by 1

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