Primary Device ID | 00859584006010 |
NIH Device Record Key | 86846ef0-7d9f-4af9-aacb-44e006c86dd5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Kinesia One |
Version Model Number | 502-0269, Tablet Assembly, WiFi |
Company DUNS | 965540359 |
Company Name | GREAT LAKES NEUROTECHNOLOGIES INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 216-619-5918 |
mphillips@glneurotech.com | |
Phone | 216-619-5918 |
mphillips@glneurotech.com | |
Phone | 216-619-5918 |
mphillips@glneurotech.com | |
Phone | 216-619-5918 |
mphillips@glneurotech.com | |
Phone | 216-619-5918 |
mphillips@glneurotech.com | |
Phone | 216-619-5918 |
mphillips@glneurotech.com | |
Phone | 216-619-5918 |
mphillips@glneurotech.com | |
Phone | 216-619-5918 |
mphillips@glneurotech.com | |
Phone | 216-619-5918 |
mphillips@glneurotech.com | |
Phone | 216-619-5918 |
mphillips@glneurotech.com | |
Phone | 216-619-5918 |
mphillips@glneurotech.com | |
Phone | 216-619-5918 |
mphillips@glneurotech.com | |
Phone | 216-619-5918 |
mphillips@glneurotech.com | |
Phone | 216-619-5918 |
mphillips@glneurotech.com | |
Phone | 216-619-5918 |
mphillips@glneurotech.com | |
Phone | 216-619-5918 |
mphillips@glneurotech.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00859584006010 [Primary] |
GYD | Transducer, Tremor |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-13 |
00859584006119 | Kinesia One, Application Software |
00859584006041 | Kinesia One, Tablet Assembly, WiFi plus Cellular |
00859584006034 | Kinesia One, WiFi plus Cellular |
00859584006027 | Kinesia One, Sensor Assembly |
00859584006010 | Kinesia One, Tablet Assembly, WiFi |
00859584006003 | Kinesia One System, WiFi |