Dynatron Soundhead

GUDID 10660584000277

Dynatronics Corporation

Physical therapy ultrasound system applicator, hand-held
Primary Device ID10660584000277
NIH Device Record Key260eac37-e9d7-495e-b431-27dee3eea8d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynatron Soundhead
Version Model NumberWSH02
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 Area2 Square centimeter
Area/Surface Area2 Square centimeter
Area/Surface Area2 Square centimeter
Area/Surface Area2 Square centimeter
Area/Surface Area2 Square centimeter
Area/Surface Area2 Square centimeter
Area/Surface Area2 Square centimeter
Area/Surface Area2 Square centimeter
Area/Surface Area2 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

Device Identifiers

Device Issuing AgencyDevice ID
GS110660584000277 [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

On-Brand Devices [Dynatron Soundhead ]

10660584000369DSH10
10660584000352DSH05
10660584000345DSH02
10660584000284WSH05
10660584000277WSH02

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