BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    Osteoboost Belt

    K Number: DEN230015 · Decision Jan 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    329

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    Basic Information

    Device Name
    Osteoboost Belt
    K Number
    DEN230015
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    888.5895
    Medical Specialty
    Orthopedic
    Decision
    Unknown
    Applicant
    Bone Health Technologies, Inc.
    Date Received
    February 17, 2023
    Decision Date
    January 12, 2024
    Product Code
    QZO
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QZO Wearable Vibration Device For Orthopedic Use