Omnisound 3000e

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…

Registry build 21.09.26

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.

4manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (3), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IMG
Manufacturer City Province Registered as Device types
Beijing Syntech Laser Co., Ltd. Beijing Beijing Contract manufacturer 5
Ebulent Optronics (Shenzhen) Ltd Shenzhen Guangdong Contract manufacturer 4
Shenzhen Dongdixin Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Xemis Medical Technology (Shenzhen) Co., Ltd. Shenzhen Guangdong Manufacturer 6

Record

Regulatory record for Omnisound 3000E
Listed by Accelerated Care Plus Corp., United States
FDA product code IMG
Device type Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device class Class 2
Regulation 21 CFR 890.5860
Establishment Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer
510(k) K883893
Record published 2016-08-16
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number
Packaging Ship carton of 4

Catalogue Numbers

Catalogue numbers for Omnisound 3000E
Catalogue number Size Status
1203000E In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Chattanooga DJO, LLC 38
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Sonicator Plus 940, 4 channel Mettler Electronics Corp. 1
Applicator 7335 Mettler Electronics Corp. 1
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LG Med Supply Drive DeVilbiss Healthcare 1
Theratouch Drive DeVilbiss Healthcare 1
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Winner EVO Combo Drive DeVilbiss Healthcare 1
OmniVersa Accelerated Care Plus Corp. 1

Showing 12 of 31. All products under Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer