Dynatron SmarTRAC

GUDID 10660584000451

Dynatronics Corporation

Intermittent powered traction system

• Primary Device ID: 10660584000451
• NIH Device Record Key: 5bad2b6e-7624-4b5f-8e8f-ede489c3bbb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynatron SmarTRAC
• Version Model Number: DSTC1
• 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

• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch
• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch
• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch
• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch
• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch
• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch
• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch
• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch
• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch
• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch
• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch
• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch
• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch
• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch
• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch
• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch
• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch
• Weight: 22 Pound
• Width: 11.8 Inch
• Length: 13.4 Inch
• Height: 8.7 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10660584000451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151640

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
• 10660584000451 - Dynatron SmarTRAC: 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