| Primary Device ID | 00859584006034 |
| NIH Device Record Key | fbacae2f-0cf1-4327-94ae-e631966dfa76 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kinesia One |
| Version Model Number | 700-0019-1, WiFi plus Cellular |
| 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 | 00859584006034 [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 |