# Easywell Biomedicals, Inc.

- Location (FDA's records): Hsinchu, TW
- FDA decisions: 2 (2017–2017): 2 510(k) clearances
- Product codes: FLL (1), NUH (1)
- Predicates its devices cite: 1 (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

## Firms whose devices it cites most
- Kaz USA, Inc (A Subsidiaryof Kaz Inc): 1 (https://510kreport.com/company/kaz-usa-a-subsidiaryof-kaz)

## Recent decisions
- K163166: EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only (Aug 11, 2017)
- K162509: Infrared Non-contact Thermometer, Model ACT8100 (Mar 10, 2017)

Source page: https://510kreport.com/company/easywell-biomedicals