Dynatron SmarTRAC

GUDID 10660584000451

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 ID10660584000451
NIH Device Record Key5bad2b6e-7624-4b5f-8e8f-ede489c3bbb3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynatron SmarTRAC
Version Model NumberDSTC1
Company DUNS113399125
Company NameDynatronics Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8008746251
Emailinfo@dynatron.com
Phone8008746251
Emailinfo@dynatron.com
Phone8008746251
Emailinfo@dynatron.com
Phone8008746251
Emailinfo@dynatron.com
Phone8008746251
Emailinfo@dynatron.com
Phone8008746251
Emailinfo@dynatron.com
Phone8008746251
Emailinfo@dynatron.com
Phone8008746251
Emailinfo@dynatron.com
Phone8008746251
Emailinfo@dynatron.com
Phone8008746251
Emailinfo@dynatron.com
Phone8008746251
Emailinfo@dynatron.com
Phone8008746251
Emailinfo@dynatron.com
Phone8008746251
Emailinfo@dynatron.com
Phone8008746251
Emailinfo@dynatron.com
Phone8008746251
Emailinfo@dynatron.com
Phone8008746251
Emailinfo@dynatron.com
Phone8008746251
Emailinfo@dynatron.com
Phone8008746251
Emailinfo@dynatron.com

Device Dimensions

Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch
Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch
Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch
Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch
Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch
Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch
Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch
Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch
Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch
Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch
Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch
Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch
Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch
Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch
Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch
Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch
Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch
Weight22 Pound
Width11.8 Inch
Length13.4 Inch
Height8.7 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110660584000451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITHEquipment, Traction, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-11-03
Device Publish Date2016-09-24

Devices Manufactured by Dynatronics Corporation

10660584000321 - Dynatron TX900+ Traction System2023-11-03
10660584000451 - Dynatron SmarTRAC 2023-11-03
10660584000451 - Dynatron SmarTRAC 2023-11-03
10660584000062 - DYNATRON ION BUTTERFLY2023-10-26
10660584000079 - Dynatron® ion™ Small2023-10-26
10660584000086 - Dynatron® ion™ Medium2023-10-26
10660584000093 - Dynatron® ion™ Large2023-10-26
10660584000185 - Solaris Soundhead2023-10-26
10660584000192 - Solaris Soundhead2023-10-26
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.