510(k) clearance
Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)
- 510(k) number
- K253431
- Applicant
- Shokz Health Global Limited
- Decision date
- Aug 19, 2026
- Date received
- Oct 1, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LXB
- Device type
- Hearing Aid, Bone Conduction
- Device class
- Class II
- Regulation
- 21 CFR 874.3302
- Advisory committee
- Ear, Nose, Throat
- Statement or summary
- Summary
- Third party
- N
- Location
- Kowloon, HK