Kinesia StimPoint 392-0067

GUDID 00859584006225

Kinesia StimPoint User Guide

GREAT LAKES NEUROTECHNOLOGIES INC.

Tremor transducer

• Primary Device ID: 00859584006225
• NIH Device Record Key: 5c516b43-397c-4175-b751-454578b1e3ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinesia StimPoint
• Version Model Number: 392-0067 Kinesia StimPoint User Guide
• Catalog Number: 392-0067
• 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: 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	00859584006225 [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