Dynatron Soundhead `

GUDID 10660584000291

Dynatronics Corporation

Physical therapy ultrasound system applicator, hand-held
Primary Device ID10660584000291
NIH Device Record Key40f73d1f-7ab0-4bb8-b932-f401b2fb9140
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynatron Soundhead `
Version Model NumberWSH10
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

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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110660584000291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2025-04-04
Device Publish Date2016-09-24

Devices Manufactured by Dynatronics Corporation

10660584000277 - Dynatron Soundhead 2025-04-04
10660584000284 - Dynatron Soundhead2025-04-04
10660584000291 - Dynatron Soundhead `2025-04-04
10660584000291 - Dynatron Soundhead `2025-04-04
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

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