Omnistim 500 Pro

Primary DI
00858703006016
Brand
Omnistim 500 Pro
Company
ACCELERATED CARE PLUS CORP
Model
100500C
Device description
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.
Published
2016-08-16
Public version status
Update
Distribution status
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
K874076000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K874076000MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATORPhysio Technology, Inc.1988-01-04IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858703006013PackageGS14In Commercial Distribution
00858703006016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085870300601310858703006013
00858703006016008587030060168587030060160858703006016

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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