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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 K261256
Device Name Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
Applicant
Shenzhen Magnet Technology Co., Ltd.
#901, Bldg. 9 Of Zhongyuntai Industrial Park, Songbai Rd., T
Shenzhen,  CN 518108
Applicant Contact Xiangshun Tian
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Riley Chen
Regulation Number874.3302
Classification Product Code
LXB  
Date Received04/16/2026
Decision Date 06/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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