Omnistim FX2 Pro

Primary DI
00858703006023
Brand
Omnistim FX2 Pro
Company
ACCELERATED CARE PLUS CORP
Model
100FX2C
Device description
The Omnistim® FX2 Pro Sport provides Patterned Electrical Neuromuscular Stimulation (PENS), which is a form ofgentle stimulation that replicates the correct firing patterns of muscles (agonist and antagonist or reciprocal musclepairs) in triphasic (ballistic), biphasic (reciprocal), or functional patterns. This approach to neuro re-ed provides ahigh intensity, precisely timed sensory input, which duplicates the firing activity of sensory neurons and musclestretch receptors during voluntary activity.
Published
2016-08-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945509000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945509000FX-2 NMS (2CHANNEL TABLE MODEL)Fx-21995-05-02IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858703006020PackageGS14In Commercial Distribution
00858703006023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085870300602010858703006020
00858703006023008587030060238587030060230858703006023

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous electrical stimulation system, line-poweredAn assembly of mains electricity (AC-powered) devices used to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy. It typically includes an electric current pulse generator, electrodes/probes, audible and/or visual indicators, and software. It may provide biofeedback and/or transcutaneous electrical nerve stimulation (TENS) to treat pain. It is typically used to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, for postsurgical calf muscle stimulation to prevent venous thrombosis, and/or to maintain or increase range of motion.

Sterilization Methods#

Method table
Method

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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Primary DI, Brand, Model table
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