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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Intelligent Mesh Nebulizer
TRUE INTEGRAL INC
NEB002
In Commercial Distribution

  • 00860003079706 ()


  • Benchtop nebulizer, non-heated
No Description
CLR Medical
S012-01-019
In Commercial Distribution

  • 00860003054901 ()
  • 00860003054987 ()


  • Surgical irrigation/aspiration cannula, non-illuminating, single-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.
Bone Health Technologies, Inc
Large
Not in Commercial Distribution

  • 00860003039748 ()
FGN-09-3004

  • Circulatory/musculoskeletal vibration therapy unit, hand-held
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.
Bone Health Technologies, Inc
Medium
Not in Commercial Distribution

  • 00860003039731 ()
FGN-09-3003

  • Circulatory/musculoskeletal vibration therapy unit, hand-held
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.
Bone Health Technologies, Inc
Small
Not in Commercial Distribution

  • 00860003039724 ()
FGN-09-3002

  • Circulatory/musculoskeletal vibration therapy unit, hand-held
Aria Free, connector tube
Inova Labs, Inc.
R0006
Not in Commercial Distribution

  • 00860003034750 ()
R0006

  • Sequential venous compression system
Companion Bag - Standard
Inova Labs, Inc.
R0005
Not in Commercial Distribution

  • 00860003034743 ()
R0005

  • Medical bag
Aria Free, small
Inova Labs, Inc.
R0004
Not in Commercial Distribution

  • 00860003034736 ()

  • Small
R0004

  • Sequential venous compression system
Aria Free, medium
Inova Labs, Inc.
R0003
Not in Commercial Distribution

  • 00860003034729 ()

  • Medium
R0003

  • Sequential venous compression system
Aria Free, large
Inova Labs, Inc.
R0002
Not in Commercial Distribution

  • 00860003034712 ()

  • Large
R0002

  • Sequential venous compression system
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