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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Bone Conduction
510(k) Number K253431
Device Name 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
Rm. 708, 7th Floor, Hang Seng Castle Peak Rd. Bldg.
339 Castle Peak Rd., Cheung Sha Wan
Kowloon,  HK
Applicant Contact Guihong Dai
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Rm. 1509, Jingting Bldg., Dongzhou Community,
Guangming St., Guangming
Shenzhen,  CN 518100
Correspondent Contact Reanny Wang
Regulation Number874.3302
Classification Product Code
LXB  
Date Received10/01/2025
Decision Date 08/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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