# SDO: Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation

- Device class: 2; regulation: 21 CFR 890.5851; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 154 days (middle half 154–154)
- 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)
- 2024: 1
- 2025: 1
- 2026: 2

## Most-cited predicates
- DEN240014: ARC-EX System (2024), cited by 3

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