DEVICE: Osteoboost (00860003039731)

Device Identifier (DI) Information

Osteoboost
Medium
Not in Commercial Distribution
FGN-09-3003
Bone Health Technologies, Inc
00860003039731
GS1
November 11, 2024
1
117605727 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61096 Circulatory/musculoskeletal vibration therapy unit, hand-held
A portable, electrically-powered device intended to non-invasively apply micro-vibrations to many regions of the body to treat diseases/ailments potentially caused by inadequate blood and lymph circulation, including but not limited to osteochondrosis, prostatitis, and arthritis. It typically consists of hand-held applicators connected to a control unit used to configure vibration frequency and duration parameters. The device may additionally apply infrared (IR) heat through the same applicators; it may be powered by in-car battery socket. The device is intended to be used in clinical and home settings.
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FDA Product Code

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Product Code Product Code Name
QZO Wearable Vibration Device For Orthopedic Use
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
DEN230015 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Storage Environment Temperature: between 50 and 104 Degrees Fahrenheit
Special Storage Condition, Specify: 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.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

d86b3577-8791-4b56-a8d0-aeee793f411e
November 11, 2024
2
October 12, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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Customer Contact

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1-833-466-7836
support@osteoboost.com
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