Omnisound 3000E - Welcome to the Omnisound® 3000 Pro, the system - ACCELERATED CARE PLUS CORP

Duns Number:828331616

Device Description: Welcome to the Omnisound® 3000 Pro, the system that redefines therapeutic ultrasound. Whil Welcome to the Omnisound® 3000 Pro, the system that redefines therapeutic ultrasound. While conceiving anddesigning 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 ofultrasound 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 - withoutswitching transducers.• Two Transducer Sizes - Our 2cm2 and 5cm2 heads offer optimum flexibility in treatment and are automaticallyenabled as you change from one to the other.• Combination Therapy - Interconnect port allows combination therapy with the Omnistim® family ofelectrostimulators.• Excellent BNR and ERA - Our superior BNR and ERA makes for highly uniform and comfortableapplications.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Omnisound 3000E

Version/Model Number

1203000E

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K883893,K883893

Product Code Details

Product Code

IMG

Product Code Name

Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

Device Record Status

Public Device Record Key

88cc4b2b-6f4f-4340-9df6-16a5200544b8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 16, 2016

Additional Identifiers

Package DI Number

10858703006006

Quantity per Package

4

Contains DI Package

00858703006009

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Ship Carton

"ACCELERATED CARE PLUS CORP" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9