50 Plus Soundhead

GUDID 10660584000260

Dynatronics Corporation

Physical therapy ultrasound system applicator Physical therapy ultrasound system applicator Physical therapy ultrasound system applicator Physical therapy ultrasound system applicator Physical therapy ultrasound system applicator Physical therapy ultrasound system applicator Physical therapy ultrasound system applicator Physical therapy ultrasound system applicator Physical therapy ultrasound system applicator Physical therapy ultrasound system applicator Physical therapy ultrasound system applicator Physical therapy ultrasound system applicator Physical therapy ultrasound system applicator Physical therapy ultrasound system applicator Physical therapy ultrasound system applicator Physical therapy ultrasound system applicator Physical therapy ultrasound system applicator Physical therapy ultrasound system applicator
Primary Device ID10660584000260
NIH Device Record Keyd22d289c-0c50-4414-adc5-d3f936bcc7a1
Commercial Distribution Discontinuation2023-10-25
Commercial Distribution StatusNot in Commercial Distribution
Brand Name50 Plus Soundhead
Version Model NumberCM10SH
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

Area/Surface Area10 Square centimeter
Area/Surface Area10 Square centimeter
Area/Surface Area10 Square centimeter
Area/Surface Area10 Square centimeter
Area/Surface Area10 Square centimeter
Area/Surface Area10 Square centimeter
Area/Surface Area10 Square centimeter
Area/Surface Area10 Square centimeter
Area/Surface Area10 Square centimeter
Area/Surface Area10 Square centimeter
Area/Surface Area10 Square centimeter
Area/Surface Area10 Square centimeter
Area/Surface Area10 Square centimeter
Area/Surface Area10 Square centimeter
Area/Surface Area10 Square centimeter
Area/Surface Area10 Square centimeter
Area/Surface Area10 Square centimeter
Area/Surface Area10 Square centimeter

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
GS110660584000260 [Primary]

FDA Product Code

IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat

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

On-Brand Devices [50 Plus Soundhead]

10660584000260CM10SH
10660584000253CM05SH
10660584000246CM02SH

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