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510(k) Data Aggregation

    K Number
    DEN230015
    Device Name
    Osteoboost Belt
    Date Cleared
    2024-01-12

    (329 days)

    Product Code
    Regulation Number
    888.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bone Health Technologies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Osteoboost Belt is indicated to reduce the decline in bone strength and volumetric bone density, as assessed via CT (computed tomography) scans that were analyzed using the O.N. Diagnostics VirtuOst estimate of vertebral bone strength and density in postmenopausal women with osteopenia of the lumbar vertebrae or total hip as diagnosed via dual x-ray absorptiometry with a bone mineral density T-score between -1.0 and -2.49. - . The clinical effects have only been observed for the duration of the clinical study performed to support the indications for use (1 year). - Fracture risk was not evaluated in the clinical study to support the indications for use, so . it is not known how the treatment effects correlate with fracture risk. - . The clinical effects have been demonstrated only for those who used the device as indicated.
    Device Description
    The Osteoboost is a wearable belt with an incorporated motor that is designed to transmit lowamplitude, high-frequency (20-40 Hz) vibration to the spine and hips. Osteoboost consists of a vibration pack mounted to a belt made of nylon-covered neoprene. The device is intended to be worn on top of a thin layer of clothing and positioned such that the vibration pack sits tightly over the sacrum. The device includes a pressure sensor under the foam pad to ensure that the device has been fastened with adequate pressure to transmit the vibration correctly. In addition, the belt incorporates an accelerometer positioned at the iliac crest which measures the actual transmission of vibration to the skeleton.
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