GaitSmart®
GaitSmart 2 is a product system that measures the gait cycle and lower limb movement of individuals. The product uses sensors, IMU’s, attached to the lower limbs that record the movement of…
GaitSmart 2 is a product system that measures the gait cycle and lower limb movement of individuals. The product uses sensors, IMU’s, attached to the lower limbs that record the movement of a client during a test. The data is then taken from each sensor and analysed, using cloud computing and results are presented back on a screen in the form of a report. The output of the Gait cycle measurement is the GaitSmart report. The report is colour coded to a normalised healthy dataset. Green → normal movement. Amber → moderate issues. Red severe issues. Furthermore, the specific numeric values are provided on the report. The report can also provide suggested standard exercises to help the person improve the parameters identified in the report. The tests can then be repeated to provide information of the changes in a client’s gait over time. This information is valuable to show progression, consistency or deterioration of a clients’ mobility.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Sintang Health&Technology Co., Ltd. | Yancheng | Jiangsu | Manufacturer | 21 |
| Shanghai Zdroid Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Guangzhou Sowen Digital Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 1 |
Record
| Listed by | Dynamic Metrics Limited |
|---|---|
| FDA product code | QKC |
| Device type | Interactive Rehabilitation Exercise Device, Prescription Use |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5360 |
| Premarket notification | Exempt |
| Record published | 2023-05-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GaitSmart2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kemtai Care | Kemtai | 5 |
| Reality DTx | Strolll, Inc. | 4 |
| Vertigenius | Digital Rehabilitation Limited | 3 |
| MindMotion GO Procedure Pack | NeuroXtherapeutics SA | 2 |
| Bits FR | Bioness Medical, Inc. | 2 |
| Strolll Rehab | Strolll, Inc. | 1 |
| MindPod Dolphin | NeuroXtherapeutics SA | 1 |
| EverEx Rehab | Everex SRL | 1 |
| YourSteps | Yoursteps Health, Inc. | 1 |
| Exer Health | Exer Labs, Inc. | 1 |
| VSTBalance | Virtusense | 1 |
| Exer Physio | Exer Labs, Inc. | 1 |
Showing 12 of 22. All products under Interactive Rehabilitation Exercise Device, Prescription Use
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.