Primary Device ID | 00859584006065 |
NIH Device Record Key | b764cd68-f939-40de-9878-7a8aadafa8de |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Kinesia 360 |
Version Model Number | 502-0271-1, Tablet Assembly |
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 | 00859584006065 [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 |
00859584006270 | Kinesia 360 Flex system is intended to monitor physical motion and muscle activity to quantify k |
00859584006263 | Kinesia 360 Tablet |
00859584006256 | Kinesia 360 System |
00859584006171 | Kinesia 360 Support Application Software |
00859584006126 | Kinesia 360, Application Software |
00859584006089 | Kinesia 360, Sensor Lower |
00859584006072 | Kinesia 360, Sensor Upper |
00859584006065 | Kinesia 360, Tablet Assembly, Samsung Galaxy |
00859584006058 | Kinesia 360, Samsung Galaxy Tablet |