BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Osteoboost

    DI: 00860003039731 · Model: Medium · Bone Health Technologies, Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Osteoboost
    Primary DI
    00860003039731
    Version / Model
    Medium
    Catalog Number
    FGN-09-3003
    Company Name
    Bone Health Technologies, Inc
    Labeler DUNS
    117605727
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-10-12
    Public Version
    2
    Public Version Date
    2024-11-11
    Public Version Status
    Update
    Public Device Record Key
    d86b3577-8791-4b56-a8d0-aeee793f411e
    Distribution End Date
    2024-11-11

    Device Description

    The Osteoboost is a wearable belt with an incorporated motor that is designed to transmit low-amplitude, high-frequency (20-40 Hz) vibration to the spine and hips. Osteoboost consists of a vibration pack mounted on a fabric belt. The vibration pack is secured tightly against the lower back with a strap that is buckled in the front and pulled tight by the patient. 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. A thin piece of foam padding is attached to the belt at the interface between the patient’s clothing and the vibration pack to improve comfort and facilitate consistent vibration transfer to the patient’s spine and hips. After belt placement and before the beginning of each treatment session, the Osteoboost performs a fit check and a calibration step to ensure that a safe and therapeutic dose is delivered to the patient. The calibration step typically takes 5-20 seconds. The device is available in three sizes and each size adjusts in belt length 5-10 inches. The size range accommodates a hip circumference from 32 to 56 inches. The device is intended to be worn and used to administer treatment during normal daily activities that involve an upright patient body position. Specifically, administer treatment during activities that involve standing and walking, such as getting ready in the morning, cooking, doing the dishes, other light household chores, going for a walk, and walking the dog.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QZO Wearable Vibration Device For Orthopedic Use

    GMDN Terms

    Code Name
    61096 Circulatory/musculoskeletal vibration therapy unit, hand-held

    Identifiers

    Type ID
    Primary 00860003039731

    Customer Contacts

    Phone
    1-833-466-7836
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    DEN230015 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    50 – 104 Degrees Fahrenheit
    Type
    Storage Environment Temperature
    Temperature Range
    50 – 104 Degrees Fahrenheit
    Type
    Special Storage Condition, Specify
    Special Conditions
    The Osteoboost does not require cleaning. Please do not attempt to wash the device. Only dab with a dry cloth if any liquids spill on the device.