Dynatron Soundhead

Basic Information

• Brand Name: Dynatron Soundhead
• Primary DI: 10660584000352
• Version / Model: DSH05
• Company Name: Dynatronics Corporation
• Labeler DUNS: 113399125
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2023-10-31
• Public Version Status: Update
• Public Device Record Key: 9c4f61c4-5f9e-492f-9627-363f871234d8
• Distribution End Date: 2023-10-31

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	Physical Medicine	890.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40774	Physical therapy ultrasound system applicator	A hand-held component of a physical therapy ultrasound system that includes a transdcer designed to convert electric voltages into ultrasound energy [e.g., frequencies greater than 20 kilohertz (kHz)] and directs this energy into body tissues. The localized thermal and nonthermal effects generated by the ultrasonic energy is associated with increased blood flow in the treated area and is intended to accelerate tissue repair. The device is typically used with ultrasound coupling gels to ensure an adequate interface with the patient. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10660584000352	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K031329	000

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	5	Square centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius