GaitSmart®

GUDID 05065010464001

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.

DYNAMIC METRICS LIMITED

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• Primary Device ID: 05065010464001
• NIH Device Record Key: 762c9ba6-0909-42e6-8e03-8c8a9a4e212f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GaitSmart®
• Version Model Number: GaitSmart2
• Company DUNS: 222720995
• Company Name: DYNAMIC METRICS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05065010464001 [Primary]

FDA Product Code

• QKC: Interactive Rehabilitation Exercise Device, Prescription Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-25
• Device Publish Date: 2023-05-17