Kinesia One

GUDID 00859584006119

Kinesia One, Application Software

GREAT LAKES NEUROTECHNOLOGIES INC.

Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer Tremor transducer

• Primary Device ID: 00859584006119
• NIH Device Record Key: 3be7916a-2d40-4f1d-84c0-10ad959c865a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinesia One
• Version Model Number: 360-0040, Application Software
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 216-619-5918
• Email: mphillips@glneurotech.com
• Phone: 216-619-5918
• Email: mphillips@glneurotech.com
• Phone: 216-619-5918
• Email: mphillips@glneurotech.com
• Phone: 216-619-5918
• Email: mphillips@glneurotech.com
• Phone: 216-619-5918
• Email: mphillips@glneurotech.com
• Phone: 216-619-5918
• Email: mphillips@glneurotech.com
• Phone: 216-619-5918
• Email: mphillips@glneurotech.com
• Phone: 216-619-5918
• Email: mphillips@glneurotech.com
• Phone: 216-619-5918
• Email: mphillips@glneurotech.com
• Phone: 216-619-5918
• Email: mphillips@glneurotech.com
• Phone: 216-619-5918
• Email: mphillips@glneurotech.com
• Phone: 216-619-5918
• Email: mphillips@glneurotech.com
• Phone: 216-619-5918
• Email: mphillips@glneurotech.com
• Phone: 216-619-5918
• Email: mphillips@glneurotech.com
• Phone: 216-619-5918
• Email: mphillips@glneurotech.com
• Phone: 216-619-5918
• Email: mphillips@glneurotech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859584006119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063872

FDA Product Code

• GYD: Transducer, Tremor

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-13

On-Brand Devices [Kinesia One]

• 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