Dynatron Solaris Plus 708

GUDID 10660584000024

Dynatronics Corporation

Multi-modality physical therapy system
Primary Device ID10660584000024
NIH Device Record Keyd4063fcc-b447-433f-8f75-74434bb60ff1
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynatron Solaris Plus 708
Version Model NumberD718T
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

Device Dimensions

Weight8.2 Pound
Height4 Inch
Width18.5 Inch
Length12 Inch
Weight8.2 Pound
Height4 Inch
Width18.5 Inch
Length12 Inch
Weight8.2 Pound
Height4 Inch
Width18.5 Inch
Length12 Inch
Weight8.2 Pound
Height4 Inch
Width18.5 Inch
Length12 Inch
Weight8.2 Pound
Height4 Inch
Width18.5 Inch
Length12 Inch
Weight8.2 Pound
Height4 Inch
Width18.5 Inch
Length12 Inch
Weight8.2 Pound
Height4 Inch
Width18.5 Inch
Length12 Inch
Weight8.2 Pound
Height4 Inch
Width18.5 Inch
Length12 Inch
Weight8.2 Pound
Height4 Inch
Width18.5 Inch
Length12 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

Device Identifiers

Device Issuing AgencyDevice ID
GS110660584000024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LIHInterferential Current Therapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-09-20
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.