# Suzhou Medical Appliance Factory

- Location (FDA's records): Costa Mesa, CA
- FDA decisions: 2 (2007–2026): 2 510(k) clearances
- Product codes: ILY (1), BWK (1)
- 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
- K260230: Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (Oct 22, 2026)
- K063568: Hwato TDP Heat Lamp, Models TDP11-DL, TDP12-XL and TDP-22XL (Mar 22, 2007)

Source page: https://510kreport.com/company/suzhou-medical-appliance-factory