Omnisound 3000E

GUDID 10858703006006

Welcome to the Omnisound® 3000 Pro, the system that redefines therapeutic ultrasound. While conceiving and designing the Omnisound® 3000 Pro, ACP set out to overcome the limitations of ordinary ultrasound devices. Here are just a few of the functions we developed that make the Omnisound® 3000 Pro truly the future of ultrasound therapy: • Controlled Depth of Penetration - The Omnisound® 3000 Pro enables you to treat soft tissue injuries, superficially with 3 MHz and instantly at the push of a button, treat deeper injuries with 1 MHz - without switching transducers. • Two Transducer Sizes - Our 2cm2 and 5cm2 heads offer optimum flexibility in treatment and are automatically enabled as you change from one to the other. • Combination Therapy - Interconnect port allows combination therapy with the Omnistim® family of electrostimulators. • Excellent BNR and ERA - Our superior BNR and ERA makes for highly uniform and comfortable applications.

ACCELERATED CARE PLUS CORP

Physical therapy ultrasound system

• Primary Device ID: 10858703006006
• NIH Device Record Key: 88cc4b2b-6f4f-4340-9df6-16a5200544b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnisound 3000E
• Version Model Number: 1203000E
• Company DUNS: 828331616
• Company Name: ACCELERATED CARE PLUS CORP
• 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: 800-350-1100
• Email: customersupport@acplus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858703006009 [Primary]
GS1	10858703006006 [Package]; Contains: 00858703006009; Package: Ship Carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K883893

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-16

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