Omnistim 500 Pro - The Omnistim® 500 Pro is designed to provide - ACCELERATED CARE PLUS CORP

Duns Number:828331616

Device Description: The Omnistim® 500 Pro is designed to provide Interferential Current Therapy (IFC), Medium The Omnistim® 500 Pro is designed to provide Interferential Current Therapy (IFC), Medium Frequency AlternatingCurrents (MFAC), Low Voltage Pulsed Current (LVPC) and High Voltage Pulsed Current Therapy (HVPC). Itstwo separate generators produce medium frequency (2000, 2500, 4000 or 5000 Hz) alternating current in continuousor modulated modes. Two isolated output circuits with independent intensity controls are provided.The Omnistim® 500 Pro MFAC and LVPC modes with fully adjustable ON and OFF times and ON and OFF rampsprovides a wide variety of uses for muscle re-education and muscle spasm reduction protocols for innervatedmuscle.The Omnistim® 500 Pro provides High Voltage Pulsed Current (HVPC) on one channel. Continuous or surgedoperation with fully adjustable ON and OFF times and ramps allow applications of HVPC therapy. Increasingcirculation, pain control and muscle re-ed can be set up in this mode.

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More Product Details

Catalog Number

-

Brand Name

Omnistim 500 Pro

Version/Model Number

100500C

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

K874076,K874076

Product Code Details

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Device Record Status

Public Device Record Key

7b9178b5-0a1a-4536-84c2-434333ff7447

Public Version Date

May 23, 2019

Public Version Number

4

DI Record Publish Date

August 16, 2016

Additional Identifiers

Package DI Number

10858703006013

Quantity per Package

4

Contains DI Package

00858703006016

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