GaitSmart®
Basic Information
- Brand Name
- GaitSmart®
- Primary DI
- 05065010464001
- Version / Model
- GaitSmart2
- Company Name
- DYNAMIC METRICS LIMITED
- Labeler DUNS
- 222720995
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-17
- Public Version
- 1
- Public Version Date
- 2023-05-25
- Public Version Status
- New
- Public Device Record Key
- 762c9ba6-0909-42e6-8e03-8c8a9a4e212f
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QKC | Interactive Rehabilitation Exercise Device, Prescription Use | Physical Medicine | 890.5360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35757 | Gait analysis system | An assembly of mains electricity (AC-powered) devices and instruments intended to be used to study walking or running patterns. The device uses a platform/mat that measures ground reaction forces or relative pressures (e.g., foot pressure mapping), and/or uses cameras to determine knee, ankle, and hip joint movements and to measure forces and torques. It can be used to diagnose problems related to walking or running and to help plan corrective actions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05065010464001 | GS1 |