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…
“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
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Fourier Intelligence Inc. | Shanghai | Shanghai | Private-label distributor | 6 |
Record
| 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
| MRI safety | MR Unsafe |
|---|---|
| Label carries | lot or batch number, serial number |
| Distribution end date | 2020-07-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PLATFORM FORCE-MEASURING | Withdrawn |
Same 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.