| Primary Device ID | 00859584006140 |
| NIH Device Record Key | f084d46a-2c32-4f37-945d-172a9b2fca24 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kinesia One-C |
| Version Model Number | 700-0028 |
| 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 | 00859584006140 [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 | 2022-09-01 |
| Device Publish Date | 2022-08-24 |
| 00859584006157 - KinesiaU | 2024-01-11 |
| 00859584006140 - Kinesia One-C | 2022-09-01Kinesia One-C system |
| 00859584006140 - Kinesia One-C | 2022-09-01 Kinesia One-C system |
| 00859584006102 - KinesiaU (iOS) | 2021-02-25 |
| 00859584006096 - KinesiaU | 2019-10-29 |
| 00859584006270 - Kinesia 360 | 2019-02-28 Kinesia 360 Flex system is intended to monitor physical motion and muscle activity to quantify kinematics of movement disorder s |
| 00859584006188 - Kinesia StimPoint | 2018-07-30 Kinesia StimPoint Sensor |
| 00859584006195 - Kinesia StimPoint | 2018-07-30 Kinesia StimPoint Application Software |
| 00859584006201 - Kinesia StimPoint | 2018-07-30 Kinesia StimPoint System |