# Changsha Yuwen Medical Equipment Co., Ltd.

- Location (FDA's records): Changsha, CN
- FDA decisions: 4 (2022–2023): 4 510(k) clearances
- Product codes: NUH (4)
- 510(k) review time since 2016: median 70 days, against 127 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K230164: TENS and EMS Stimulation (OTC) (Apr 10, 2023)
- K230174: TENS and EMS Stimulation (OTC) (Mar 20, 2023)
- K230163: TENS and EMS Stimulation (OTC) (Mar 20, 2023)
- K212184: TENS and EMS Stimulation (OTC) (Apr 1, 2022)

Source page: https://510kreport.com/company/changsha-yuwen-medical-equipment
