Balance Advantage Essential Spark System
Bertec Balance Advantage Essential Spark system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
1manufacturer
1catalogue number
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 |
| Record revised | 2025-06-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 97P-0077 | 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.