DEVICE: Osteoboost (00860003039724)

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.