Solaris Soundhead

GUDID 10660584000192

Dynatronics Corporation

Physical therapy ultrasound system applicator

• Primary Device ID: 10660584000192
• NIH Device Record Key: 16bce917-2c18-460d-b3ed-bdec4bb7b620
• Commercial Distribution Discontinuation: 2023-10-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solaris Soundhead
• Version Model Number: 9GSH05
• Company DUNS: 113399125
• Company Name: Dynatronics Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com

Device Dimensions

• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter
• Area/Surface Area: 5 Square centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10660584000192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031329

FDA Product Code

• IMI: Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-10-26
• Device Publish Date: 2016-09-24

On-Brand Devices [Solaris Soundhead]

• 10660584000208: 9GSH10
• 10660584000192: 9GSH05
• 10660584000185: 9GSH02