Eu Mdr Eu Md Class 1 On The Market ๐Ÿ‡บ๐Ÿ‡ธ United States

MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER

Great Lakes NeuroTechnologies Inc ยท ๐Ÿ‡บ๐Ÿ‡ธ United States
Devices (same UDI-DI)
6
Certificates
0
Countries
32
Notified Bodies
0

Basic Information

Primary DI
00859584006058
Basic UDI-DI Code
0859584006KinesiaWG
Reference
Kinesia 360 700-0019-2
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market

Additional Description

The Kinesia 360โ„ข motor assessment system provides low burden method for remote, continuous measurement of patient symptoms. Sensors worn on the wrist and ankle combined with a mobile application continuously record data for assessment of tremor, slowness, dyskinesia and mobility. Data from the motion sensors is uploaded to the Kinesia Web Portal and algorithms are used to detect symptoms and calculate severity scores every two minutes on a scale shown to be highly correlated with clinician ratings.

CND Nomenclature Codes

Code Description
W01010899 MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER

Available In Countries

๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡ธ Iceland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡ฎ Liechtenstein ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

Related Devices

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

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