Dynatron TX900+ Traction System

GUDID 10660584000321

Dynatronics Corporation

Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system

• Primary Device ID: 10660584000321
• NIH Device Record Key: 2ab6f4d1-be0c-4753-9d9a-306f0ad77b74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynatron TX900+ Traction System
• Version Model Number: TX900+
• Company DUNS: 113399125
• Company Name: Dynatronics Corporation
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com

Device Dimensions

• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch
• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch
• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch
• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch
• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch
• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch
• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch
• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch
• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch
• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch
• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch
• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch
• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch
• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch
• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch
• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch
• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch
• Height: 10.6 Inch
• Width: 10.6 Inch
• Length: 13.4 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10660584000321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993919

FDA Product Code

• ITH: Equipment, Traction, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-11-03
• Device Publish Date: 2016-09-24

Devices Manufactured by Dynatronics Corporation

• 10660584000321 - Dynatron TX900+ Traction System: 2023-11-03
• 10660584000321 - Dynatron TX900+ Traction System: 2023-11-03
• 10660584000451 - Dynatron SmarTRAC: 2023-11-03
• 10660584000062 - DYNATRON ION BUTTERFLY: 2023-10-26
• 10660584000079 - Dynatron® ion™ Small: 2023-10-26
• 10660584000086 - Dynatron® ion™ Medium: 2023-10-26
• 10660584000093 - Dynatron® ion™ Large: 2023-10-26
• 10660584000185 - Solaris Soundhead: 2023-10-26
• 10660584000192 - Solaris Soundhead: 2023-10-26