Titronics

GUDID 00860447001714

The C-7000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by chiropractors. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care, similar to a common thermometer

TITRONICS RESEARCH & DEVELOPMENT COMPANY

Thermographic camera

• Primary Device ID: 00860447001714
• NIH Device Record Key: 8e670d2c-e071-4609-bd0d-d30dc87f1688
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titronics
• Version Model Number: Tytron C-7000
• Company DUNS: 073499345
• Company Name: TITRONICS RESEARCH & DEVELOPMENT COMPANY
• 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: 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: 319-545-7377
• Email: chris@titronics.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 700 millibar and 1025 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1025 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1025 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1025 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1025 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1025 millibar

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860447001714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974208

FDA Product Code

• HCS: Device, Temperature Measurement, Direct Contact, Powered

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: 2019-02-21
• Device Publish Date: 2019-01-21

On-Brand Devices [Titronics]

• 00860447001721: The Titronics range of motion device is a dual inclinometer system. A goniometer is powered dev
• 00860447001714: The C-7000 is indicated for use in detecting, measuring, recording, and graphing the skin surfac
• 00860447001707: The C-5000 is indicated for use in detecting, measuring, recording, and graphing the skin surfac
• 00860447001738: The C-5000 is indicated for use in detecting, measuring, recording, and graphing the skin surfac