glneurotech.comKinesiaU - 700-0027 KinesiaU Kit
2024-01-03
GREAT LAKES NEUROTECHNOLOGIES INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009134706 | 3009134706 | GREAT LAKES NEUROTECHNOLOGIES INC. | 1 | N | 2026-01-01 | 6100 Rockside Woods Blvd. Suite 415 Cleveland OH US 44131 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00859584006003 | Kinesia One - Kinesia One System, WiFi | 216-619-5918 | mphillips@glneurotech.com |
| 00859584006010 | Kinesia One - Kinesia One, Tablet Assembly, WiFi | 216-619-5918 | mphillips@glneurotech.com |
| 00859584006027 | Kinesia One - Kinesia One, Sensor Assembly | 216-619-5918 | mphillips@glneurotech.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 127813 | 1836158788 | K063872 | KINESIA | GYD | 2007-04-06 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GYD | 1 | 2007-04-06 |
GUDID#
Kinesia One-C - Kinesia One-C system
2022-08-24
KinesiaU (iOS) - 700-0026
2021-02-17
KinesiaU - 700-0025
2019-10-21
Kinesia One - Kinesia One System, WiFi
2016-09-12
Kinesia One - Kinesia One, Tablet Assembly, WiFi
2016-09-13
Kinesia One - Kinesia One, Sensor Assembly
2016-09-13
Kinesia One - Kinesia One, WiFi plus Cellular
2016-09-13
Kinesia One - Kinesia One, Tablet Assembly, WiFi plus Cellular
2016-09-13
Kinesia 360 - Kinesia 360, Samsung Galaxy Tablet
2016-09-13
Kinesia 360 - Kinesia 360, Tablet Assembly, Samsung Galaxy
2016-09-13
Kinesia 360 - Kinesia 360, Sensor Upper
2016-09-13
Kinesia 360 - Kinesia 360, Sensor Lower
2016-09-13
Kinesia One - Kinesia One, Application Software
2016-09-13
Kinesia 360 - Kinesia 360, Application Software
2016-09-13
Kinesia - Kinesia Web Application/Portal 1 Software
2016-09-13
Kinesia - Kinesia Web Application/Portal 2 Software
2016-11-10
Kinesia 360 - Kinesia 360 Support Application Software
2017-02-23
Kinesia StimPoint - Kinesia StimPoint Sensor
2018-06-27
Kinesia StimPoint - Kinesia StimPoint Application Software
2018-06-27
Kinesia StimPoint - Kinesia StimPoint System
2018-06-27
Kinesia StimPoint - Kinesia StimPoint Tablet Assembly
2018-06-27
Kinesia StimPoint - Kinesia StimPoint User Guide
2018-06-27
Kinesia - Kinesia Finger Sleeves
2018-06-27
Kinesia - Kinesia Charging Pad
2018-06-27
Kinesia 360 - Kinesia 360 System
2018-06-27
Kinesia 360 - Kinesia 360 Tablet
2018-06-27
Kinesia 360 - Kinesia 360 Flex system is intended to monitor physical motion and muscle activity to quantify kinematics of movement disorder symptoms and assess activity in any instance where quantifiable analysis of motion and muscle activity is desired.
2019-01-28