Dynatron Ion Small

GUDID 20660584000076

Dynatronics Corporation

Iontophoresis system electrode, return Iontophoresis system electrode, return Iontophoresis system electrode, return Iontophoresis system electrode, return Iontophoresis system electrode, return Iontophoresis system electrode, return Iontophoresis system electrode, return Iontophoresis system electrode, return Iontophoresis system electrode, return Iontophoresis system electrode, return Iontophoresis system electrode, return Iontophoresis system electrode, return Iontophoresis system electrode, return Iontophoresis system electrode, return Iontophoresis system electrode, return
Primary Device ID20660584000076
NIH Device Record Key4cb5fd81-82fa-47e0-9e7d-489490a447d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynatron Ion Small
Version Model NumberION-S
Company DUNS113399125
Company NameDynatronics Corporation
Device Count12
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

Device Dimensions

Area/Surface Area1.2 Square inch
Area/Surface Area1.2 Square inch
Area/Surface Area1.2 Square inch
Area/Surface Area1.2 Square inch
Area/Surface Area1.2 Square inch
Area/Surface Area1.2 Square inch
Area/Surface Area1.2 Square inch
Area/Surface Area1.2 Square inch
Area/Surface Area1.2 Square inch
Area/Surface Area1.2 Square inch
Area/Surface Area1.2 Square inch
Area/Surface Area1.2 Square inch
Area/Surface Area1.2 Square inch
Area/Surface Area1.2 Square inch
Area/Surface Area1.2 Square inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110660584000079 [Unit of Use]
GS120660584000076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2015-11-20

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.