Ultratone USFPC1

GUDID 05056119700008

Futura Pro (US Specification) System comprising: Console, Body Applicator, and 1MHz Ultrasound Applicator.

ULTRATONE SCIENTIFIC INSTRUMENTS LIMITED

Physical therapy ultrasound/neuromuscular stimulation system

• Primary Device ID: 05056119700008
• NIH Device Record Key: 31fe3727-752c-4519-9f18-62880b146221
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultratone
• Version Model Number: Futura Pro (US Specification)
• Catalog Number: USFPC1
• Company DUNS: 226427250
• Company Name: ULTRATONE SCIENTIFIC INSTRUMENTS LIMITED
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056119700008 [Primary]

FDA Product Code

• IMG: Stimulator, Ultrasound And Muscle, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-25