BeamMed

Basic Information

• Brand Name: BeamMed
• Primary DI: 72990012704126
• Version / Model: PLATFORM FORCE-MEASURING
• Company Name: BEAMMED LTD
• Labeler DUNS: 534155155
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-25
• Public Version: 4
• Public Version Date: 2020-07-10
• Public Version Status: Update
• Public Device Record Key: f24cf516-1be0-475b-a5e5-72a825113bb7
• Distribution End Date: 2020-07-09

Device Description

"Tetrax balance assessment is used to quantitatively detect changes in postural responses that have been shown to be indicative of the presence of a disturbance or pathology that affects balance and posture. It is used for the assessment of fall risk and as an aid in the diagnosis of a number of conditions that affect balance. The device designed in tour different modifications: Tetrax system contains platform and railing and Tetrax Free Plates that includes only 2 balance plates. The Tetrax provides valuable information concerning the functioning of neuro-physiological centers of postural control. This information assists the physician in confirming clinical impressions or suspicions. It helps to focus tests prescribed for the patient, and, more important, limits unnecessary tests, especially in cases of dizziness, vertigo, tiredness, and many other balance disorders or pathologies. The Tetrax system offers the possibility of evaluating the effects of therapeutic interventions in such cases. The system is capable of providing the physician with a comprehensive assessment of postural control and therefore may be used to assess accident proneness due to fatigue, stress, and/or intoxication. The Tetrax system provides valuable information on the effectiveness of prosthetic devices, including prostheses, splints, corsets, etc. Tetrax has wide application in the field of child psychology and developmental pediatrics and can be used in children for detecting neuro-physiological sources of insufficient school readiness, learning disabilities, dyslexia, Attention Deficit Disorders (ADD), etc. The Tetrax device includes a balance platform with a USB connector and software supplied on a CD for installation on a standard PC or an Omnisense device. The Tetrax balance platform is a platform that includes four separate plates. The subject stands on the platform, with each heel and toe-part on one of the four plates, guided by a foot-shaped sketch on each of the plates. Within

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KHX	Platform, Force-Measuring	Physical Medicine	890.1575	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40779	Bone absorptiometric ultrasound system	An assembly of devices used to produce bone density measurements and other calculations based on data obtained from transmitted and reflected ultrasound (US) waves. Also called a bone densitometer, it has an integrated ultrasound transducer to deliver an ultrasound beam to an anatomical region of interest. Information obtained from detection and analysis of resulting echoes is used in calculations to estimate bone mineral density or subcutaneous fat, or to make other quantitative assessments (e.g., fracture risk). It typically incorporates an ultrasound transducer, detection electronics, a control panel, a computer, software programs, a video display, and a patient positioning system (PPS).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	72990012704126	GS1