Duns Number:828331616
Device Description: The Omnistim® FX2 Pro provides Patterned Electrical Neuromuscular Stimulation (PENS), whic The Omnistim® FX2 Pro provides Patterned Electrical Neuromuscular Stimulation (PENS), which is a form ofstimulation that replicates the correct firing patterns of muscles (agonist and antagonist or reciprocal muscle pairs) intriphasic (ballistic), biphasic (reciprocal), or functional patterns. This approach to neuro re-ed provides a highintensity, precisely timed sensory input, which duplicates the firing activity of sensory neurons and muscle stretchreceptors during voluntary activity.
Catalog Number
-
Brand Name
Omnistim FX2 Pro Sport
Version/Model Number
100FX2D
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K945509,K945509
Product Code
IPF
Product Code Name
Stimulator, Muscle, Powered
Public Device Record Key
10070f27-d911-4268-b25f-a780f0c4d769
Public Version Date
May 23, 2019
Public Version Number
4
DI Record Publish Date
August 16, 2016
Package DI Number
10858703006037
Quantity per Package
4
Contains DI Package
00858703006030
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |