Dynatron iBOX2

GUDID 10660584000314

Dynatronics Corporation

Drug-delivery iontophoresis system generator Drug-delivery iontophoresis system generator Drug-delivery iontophoresis system generator Drug-delivery iontophoresis system generator Drug-delivery iontophoresis system generator Drug-delivery iontophoresis system generator Drug-delivery iontophoresis system generator Drug-delivery iontophoresis system generator Drug-delivery iontophoresis system generator Drug-delivery iontophoresis system generator Drug-delivery iontophoresis system generator Drug-delivery iontophoresis system generator Drug-delivery iontophoresis system generator Drug-delivery iontophoresis system generator Drug-delivery iontophoresis system generator Drug-delivery iontophoresis system generator Drug-delivery iontophoresis system generator Drug-delivery iontophoresis system generator
Primary Device ID10660584000314
NIH Device Record Key82df4cc2-124c-4129-ab3d-3e827ba9e9bf
Commercial Distribution Discontinuation2023-10-25
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDynatron iBOX2
Version Model NumberDIBOX2
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

Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch
Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch
Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch
Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch
Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch
Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch
Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch
Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch
Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch
Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch
Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch
Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch
Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch
Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch
Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch
Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch
Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch
Weight0.225 Pound
Height1.3 Inch
Width2.66 Inch
Length4.5 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110660584000314 [Primary]

FDA Product Code

EGJDevice, Iontophoresis, Other Uses

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-10-26
Device Publish Date2016-09-24

Devices Manufactured by Dynatronics Corporation

10660584000321 - Dynatron TX900+ Traction System2023-11-03
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.