# Shokz Health Global Limited

- Location (FDA's records): Kowloon, HK
- FDA decisions: 1 (2026–2026): 1 510(k) clearance
- Product codes: LXB (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
- Cochlear Americas: 1 (https://510kreport.com/company/cochlear-americas)

## Recent decisions
- K253431: Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) (Aug 19, 2026)

Source page: https://510kreport.com/company/shokz-health-global