KinesiaU (iOS) 700-0026

GUDID 00859584006102

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 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: 00859584006102
• NIH Device Record Key: 80c202ee-de20-4ea5-9ca5-d8ae68096ded
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KinesiaU (iOS)
• Version Model Number: 700-0026
• Catalog Number: 700-0026
• 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	00859584006102 [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: 2021-02-25
• Device Publish Date: 2021-02-17

Devices Manufactured by GREAT LAKES NEUROTECHNOLOGIES INC.

• 00859584006157 - KinesiaU: 2024-01-11
• 00859584006140 - Kinesia One-C: 2022-09-01 Kinesia One-C system
• 00859584006102 - KinesiaU (iOS): 2021-02-25
• 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