Omnistim FX2 Pro Sport

Basic Information

• Brand Name: Omnistim FX2 Pro Sport
• Primary DI: 00858703006030
• Version / Model: 100FX2D
• Company Name: ACCELERATED CARE PLUS CORP
• Labeler DUNS: 828331616
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-16
• Public Version: 5
• Public Version Date: 2023-08-18
• Public Version Status: Update
• Public Device Record Key: 10070f27-d911-4268-b25f-a780f0c4d769
• Distribution End Date: 2023-08-17

Device Description

The Omnistim® FX2 Pro provides Patterned Electrical Neuromuscular Stimulation (PENS), which is a form of 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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IPF	Stimulator, Muscle, Powered	Physical Medicine	890.5850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858703006030	GS1
Package	10858703006037	GS1		4	Not in Commercial Distribution	2023-08-17

Customer Contacts

• Phone: [phone]
• Email: [email protected]