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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
Resorbable implant for anterior cruciate ligament (ACL) repair. A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.
Miach Orthopaedics, Inc.
1000
In Commercial Distribution
- 00860002987804 ()
- Joint cartilage biomatrix implant
Flexible Access Port Kit
Cannuflow, Inc.
SportPort 6.5 x 6
In Commercial Distribution
- 20860002896940 ()
- 00860002896946 ()
- Lumen/Inner Diameter: 6.5 Millimeter
- Length: 6 Centimeter
Sport 6-6
- Arthroscopic access cannula, single-use
Flexible Access Portal Kit
Cannuflow, Inc.
SportPort 8.5 x 6
In Commercial Distribution
- 20860002896933 ()
- 00860002896939 ()
- Lumen/Inner Diameter: 8.5 Millimeter
- Length: 6 Centimeter
SPORT 8-6
- Arthroscopic access cannula, single-use
Filtered tubing set to attach MicroDryer to endoscope
GI Scientific LLC
Filtered Air Tubing Set
In Commercial Distribution
- 00860002853116 ()
- 00860002853178 ()
VMD-06-00008
- Surgical instrument/endoscope cleaning utensil, single-use
Flexible endoscope channel dryer
GI Scientific LLC
Endoscope Channel Dryer Large
In Commercial Distribution
- 00860002853116 ()
- 00860002853161 ()
VDL-06-00006
- Surgical instrument/endoscope cleaning utensil, single-use
PC Based Wireless 12 Lead EKG Device
MEMTEC CORPORATION
MobileECG System
In Commercial Distribution
- 00860002827315 ()
- Electrocardiograph, professional, single-channel
Proov PdG, Progesterone Metabolite Test. The only FDA-Cleared Test to Confirm Successful Ovulation at Home.
Mfb Fertility, Inc.
Confirm
In Commercial Distribution
- 00860002790817 ()
- Natural conception assistance kit
No Description
JERON ELECTRONIC SYSTEMS, INC.
Provider 700
In Commercial Distribution
- 00860002736037 ()
Provider 700
- Nurse call system
No Description
JERON ELECTRONIC SYSTEMS, INC.
Provider 790
In Commercial Distribution
- 00860002736020 ()
Provider 790
- Nurse call system