BeamMed

"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…

Registry build 21.09.26

“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

1manufacturer
1catalogue number

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code KHX
Manufacturer City Province Registered as Device types
Fourier Intelligence Inc. Shanghai Shanghai Private-label distributor 6

Record

Regulatory record for BeamMed
Listed by BeamMed Ltd., Israel
FDA product code KHX
Device type Platform, Force-Measuring
Device class Class 1
Regulation 21 CFR 890.1575
Establishment Manufacturer
Premarket notification Exempt
Record published 2017-01-25
Record revised 2020-07-10 (version 4)

Specifications

Specifications
MRI safety MR Unsafe
Label carries lot or batch number, serial number
Distribution end date 2020-07-09

Catalogue Numbers

Catalogue numbers for BeamMed
Catalogue number Size Status
PLATFORM FORCE-MEASURING Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Balance SD Sport Medical Technology Inc 3
Kinvent Kinvent Hellas 2
Assess Balance Balance Tracking Systems Incorporated 1
VibroTactile Sport Medical Technology Inc 1
FDM-S Zebris Medical Gmbh 1
KForce Deltas Kinvent Biomecanique 1
Diers pedogait Diers International Gmbh 1
FDM-2 System Zebris Medical Gmbh 1
Biosway Sport Medical Technology Inc 1
BTrackS Balance Plate Balance Tracking Systems Incorporated 1
MotionVR Virtualis 1
FDM-SX Zebris Medical Gmbh 1

Showing 12 of 35. All products under Platform, Force-Measuring

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer