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

Gait analysis system
Primary Device ID05065010464001
NIH Device Record Key762c9ba6-0909-42e6-8e03-8c8a9a4e212f
Commercial Distribution StatusIn Commercial Distribution
Brand NameGaitSmart®
Version Model NumberGaitSmart2
Company DUNS222720995
Company NameDYNAMIC METRICS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105065010464001 [Primary]

FDA Product Code

QKCInteractive Rehabilitation Exercise Device, Prescription Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-25
Device Publish Date2023-05-17

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