510(k) K253431 ยท LXB Hearing Aid, Bone Conduction
Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)
| Applicant | Shokz Health Global Limited, Kowloon, HK |
| Decision | Substantially Equivalent, Aug 19, 2026 |
| Received | Oct 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253431
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.