Kinesia 502-0268

GUDID 00859584006232

Kinesia Finger Sleeves

GREAT LAKES NEUROTECHNOLOGIES INC.

Tremor transducer

• Primary Device ID: 00859584006232
• NIH Device Record Key: 5cc1e101-2b71-487e-8fd0-96b416048ba2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinesia
• Version Model Number: 502-0268 Kinesia Finger Sleeves
• Catalog Number: 502-0268
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859584006232 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-30
• Device Publish Date: 2018-06-27

On-Brand Devices [Kinesia]

• 00859584006249: Kinesia Charging Pad
• 00859584006232: Kinesia Finger Sleeves
• 00859584006164: Kinesia Web Application/Portal 2 Software
• 00859584006133: Kinesia Web Application/Portal 1 Software