MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER

Primary DI

00859584006003

Basic UDI-DI Code

0859584006KinesiaWG

Reference

Kinesia ONE 700-0019

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Great Lakes NeuroTechnologies Inc

The Kinesia ONE™ motor assessment system provides highly sensitive motor symptom assessment by having the patient perform brief pre-defined tasks based on common rating scales (e.g., UPDRS, TETRAS). A mobile application guides patients through donning the motion sensor on their finger or heel and provides intuitive instructions for completing the assessment tasks. Data from the motion sensor is uploaded to the Kinesia Web Portal in real-time and algorithms are used to calculate severity scores on a 0-4 rating scale shown to be highly correlated with clinician ratings.

The Basic UDI-DI associated with this device has 6 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).