# Soberlink Healthcare, LLC

- Location (FDA's records): Huntington Beach, CA
- FDA decisions: 1 (2016–2016): 1 510(k) clearance
- Product codes: DJZ (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
- Pas Systems International, Inc.: 1 (https://510kreport.com/company/pas-systems-international)

## Recent decisions
- K160613: Soberlink Cellular Device and Sober Sky Web Portal (Jul 14, 2016)

Source page: https://510kreport.com/company/soberlink-healthcare