Balance Advantage Computerized Dynamic Posturography System
The Computerized Dynamic Posturography (CDP ) system is a clinical balance assessment device that collects and analyzes force and moment data from a balance plate. The balance plate is…
The Computerized Dynamic Posturography (CDP ) system is a clinical balance assessment device that collects and analyzes force and moment data from a balance plate. The balance plate is seated in a dynamic chassis that can move in both translational and rotational directions, under control of the Balance Advantage (BA) software program. The BA software contains both assessment and training modules that can be used during each session. Assessments have set run-times during which they collect data after the “Start” button is pressed, while trainings have customizable run-times varying from 1 minute to 15 minutes. The system is intended to be used by trained clinicians in a hospital or clinical (physical therapy or ENT) environment who operate the software and ensure the safety of the patient. The patient being assessed on the system is placed in a harness. There are three different harness sizes with varying weight limits that can be purchase with the system; standard harness supports up to 300lbs, pediatric is up to 100lbs, and the bariatric supports up to 450lbs. The mechanical components of the system are designed to support up to 500lb patients.
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 | Bertec Corp., United States |
|---|---|
| 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 | 2021-01-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 97P-0036 | In distribution |
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.