FDA.reportPublic FDA data

OmniVersa High Conductivity Electrodes

Primary DI
10858703006303
Brand
OmniVersa High Conductivity Electrodes
Company
ACCELERATED CARE PLUS CORP
Model
26135
Device description
OmniVersa High Conductivity Electrodes, 2.75 x 5
Published
2022-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858703006303PackageGS14In Commercial Distribution
20858703006300PackageGS110In Commercial Distribution
30858703006307PackageGS110In Commercial Distribution
00858703006306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085870300630310858703006303
2085870300630020858703006300
3085870300630730858703006307
00858703006306008587030063068587030063060858703006306

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode, single-useAn electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity35 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Handling Environment Temperature40 Degrees Fahrenheit80.6 Degrees Fahrenheit
Storage Environment Humidity35 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Storage Environment Temperature40 Degrees Fahrenheit80.6 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
828331616
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858703006054Neuroprobe 500 Pro140500B2016-08-16
00858703006252Ultraphonic (250ml Bottle)455392016-09-06
00858703006269Ultraphonic, 5 Liter w/ bottle320602016-09-06
00858703006061Omnipad Light Therapy, Dual 5x7 Pads768962016-08-16
00858703006399OmniCycle Elite 7 Inch Screen Motorized Therapeutic Exercise SystemA007-5332024-10-21
00858703006382OmniTour System300800T2024-09-10
00858703006207Synchrony Oro-Facial sEMG Electrode618792016-08-16
00858703006214Electrodes Pharyngeal sEMG341842016-08-16
00858703006375OmniTourOmniTourSoftware2023-09-12
00858703006313OmniFlow SoftwareFlowSoftware2023-09-06
00858703006092OmniStim FX2 Portable PENS300200A-12016-08-16
00858703006276OmniFlow Therapy System100FLO2023-09-12
00858703006344ACPlus Respiratory AssessmentARASoftware2023-09-12
00858703006368ACPlus Platform100ACPLUS2023-09-12
B179OMNI13E87E4OmnisEMG441442023-09-06
00858703006337Synchrony Dysphagia Solutions by ACP300800A2023-09-01
00858703006351OmniVR Elite300600C2023-09-01
00858703006139OmniVersa100FXF2023-08-17
00858703006320OmniME100MTS2023-08-17
00858703006078Megapulse II19030292016-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973602730894MEDLOTTOP-RANK HEALTH CARE CO., LTD.GXY2026-06-08
08720791379032Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379049Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379063Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379087Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
00816312028072Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-06-01
00850055335004iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335011iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335028iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02