Solaris Soundhead

GUDID 10660584000192

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 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 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

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

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

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