FDA.reportPublic FDA data

Omnisound 3000E

Primary DI
00858703006009
Brand
Omnisound 3000E
Company
ACCELERATED CARE PLUS CORP
Model
1203000E
Device description
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.
Published
2016-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep HeatPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K883893000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K883893000OMNISOUND(TM) 3000Physio Technology, Inc.1988-11-01IMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858703006006PackageGS14In Commercial Distribution
00858703006009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085870300600610858703006006
00858703006009008587030060098587030060090858703006009

Contacts#

Phone, Email table
PhoneEmail
800-350-1100customersupport@acplus.com

Regulatory Flags#

DUNS number
828331616
Device count
1
Serial number
true
Manufacturing date on label
true

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