AccessGUDID - DEVICE: Omnistim FX2 Pro (00858703006023)

GUDID

Device Identifier (DI) Information

Brand Name: Omnistim FX2 Pro
Version or Model: 100FX2C
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ACCELERATED CARE PLUS CORP

Primary DI Number: 00858703006023
Issuing Agency: GS1
Commercial Distribution End Date: August 17, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 828331616 *Terms of Use

Device Description: The Omnistim® FX2 Pro Sport provides Patterned Electrical Neuromuscular Stimulation (PENS), which is a form of gentle stimulation that replicates the correct firing patterns of muscles (agonist and antagonist or reciprocal muscle pairs) in triphasic (ballistic), biphasic (reciprocal), or functional patterns. This approach to neuro re-ed provides a high intensity, precisely timed sensory input, which duplicates the firing activity of sensory neurons and muscle stretch receptors during voluntary activity.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46573	Physical therapy transcutaneous neuromuscular electrical stimulation system	An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IPF	Stimulator, Muscle, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 67bbd277-0eab-4d60-ae21-8c94a6004009
Public Version Date: August 18, 2023
Public Version Number: 5
DI Record Publish Date: August 16, 2016