BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)

    K Number: K261256 · Decision Jun 11, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    50
    Applicant Total
    1
    Review Days
    56

    Basic Information

    Device Name
    Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
    K Number
    K261256
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3302
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Magnet Technology Co., Ltd.
    Date Received
    April 16, 2026
    Decision Date
    June 11, 2026
    Product Code
    LXB
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LXB Hearing Aid, Bone Conduction

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LXB), ordered by most recent decision date.

    Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)

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