Kinesia One

GUDID 00859584006003

Kinesia One System, WiFi

GREAT LAKES NEUROTECHNOLOGIES INC.

Tremor transducer
Primary Device ID00859584006003
NIH Device Record Key61399f43-5435-46ce-bdec-ed9671d146f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameKinesia One
Version Model Number700-0019, WiFi
Company DUNS965540359
Company NameGREAT LAKES NEUROTECHNOLOGIES INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone216-619-5918
Emailmphillips@glneurotech.com
Phone216-619-5918
Emailmphillips@glneurotech.com
Phone216-619-5918
Emailmphillips@glneurotech.com
Phone216-619-5918
Emailmphillips@glneurotech.com
Phone216-619-5918
Emailmphillips@glneurotech.com
Phone216-619-5918
Emailmphillips@glneurotech.com
Phone216-619-5918
Emailmphillips@glneurotech.com
Phone216-619-5918
Emailmphillips@glneurotech.com
Phone216-619-5918
Emailmphillips@glneurotech.com
Phone216-619-5918
Emailmphillips@glneurotech.com
Phone216-619-5918
Emailmphillips@glneurotech.com
Phone216-619-5918
Emailmphillips@glneurotech.com
Phone216-619-5918
Emailmphillips@glneurotech.com
Phone216-619-5918
Emailmphillips@glneurotech.com
Phone216-619-5918
Emailmphillips@glneurotech.com
Phone216-619-5918
Emailmphillips@glneurotech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100859584006003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GYDTransducer, Tremor

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-12

On-Brand Devices [Kinesia One]

00859584006119Kinesia One, Application Software
00859584006041Kinesia One, Tablet Assembly, WiFi plus Cellular
00859584006034Kinesia One, WiFi plus Cellular
00859584006027Kinesia One, Sensor Assembly
00859584006010Kinesia One, Tablet Assembly, WiFi
00859584006003Kinesia One System, WiFi

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