# Wondfo USA Co, Ltd.

- Location (FDA's records): San Diego, CA
- FDA decisions: 2 (2025–2025): 2 510(k) clearances
- Product codes: SCA (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 4 (1 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
- Healgen: 1 (https://510kreport.com/company/healgen)

## Firms that cite its devices most
- Ihealth Labs, Inc.: 2 (https://510kreport.com/company/ihealth-labs)
- Access Bio, Inc.: 1 (https://510kreport.com/company/access-bio)

## Its most-cited devices
- K243256: WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest (2025), cited by 4

## Recent decisions
- K251563: WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test (Aug 20, 2025)
- K243256: WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest (Jan 16, 2025)

Source page: https://510kreport.com/company/wondfo-usa