| Primary Device ID | 00859584006263 |
| NIH Device Record Key | 7021bc51-6d7b-46fc-9794-fe3a99aee876 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kinesia 360 |
| Version Model Number | 502-0271-1 K360 Tablet |
| Catalog Number | 502-0271-1 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859584006263 [Primary] |
| GYD | Transducer, Tremor |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-30 |
| Device Publish Date | 2018-06-27 |
| 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 |