Kinesia StimPoint 700-0024

GUDID 00859584006201

Kinesia StimPoint System

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: 00859584006201
• NIH Device Record Key: f2874438-fe91-4975-814c-7ccbcd458894
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinesia StimPoint
• Version Model Number: 700-0024 Kinesia StimPoint System
• Catalog Number: 700-0024
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859584006201 [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 StimPoint ]

• 00859584006225: Kinesia StimPoint User Guide
• 00859584006218: Kinesia StimPoint Tablet Assembly
• 00859584006201: Kinesia StimPoint System
• 00859584006195: Kinesia StimPoint Application Software
• 00859584006188: Kinesia StimPoint Sensor