FDA.reportPublic FDA data

WalkAide Electrodes - package of 4

Primary DI
00858184006079
Brand
WalkAide Electrodes - package of 4
Company
INNOVATIVE NEUROTRONICS, INC.
Model
20-0500
Device description
Transcutaneous Electrical Stimulation Electrode
Published
2016-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K874469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K874469000TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)Axelgaard Mfg. Co., Ltd.1988-01-28GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
858184006086PackageGS110In Commercial Distribution
00858184006079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
858184006086008581840060868581840060860858184006086
00858184006079008581840060798581840060790858184006079

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile 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, 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-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-884-6462info@ininc.us

Regulatory Flags#

DUNS number
791468734
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858184006017WalkAide Kit20-10002016-08-16
10858184006458WalkAide20-05902018-11-26
20858184006455WalkAide20-05912018-11-26
00858184006109WalkAide 1.25 Premium Electrodes - pkg of 420-05212016-08-16
00858184006123WalkAide 1.875 Premium Electrodes - pkg of 420-05402016-08-16
00858184006451WalkAide20-05802018-11-26
00858184006000WalkAide Unit20-01002016-08-16
00858184006031WalkAide Kit for Japan21-10002016-08-16
00858184006048WalkAide Kit for Demo Use20-10022016-08-16
00858184006055WalkLink Unit20-03102016-08-16
00858184006062WalkLink System ((Clinician Kit)20-03002016-08-16
00858184006130WalkAnalyst Software Kit20-06032016-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
08720791372163CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372187CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372200CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372224CadwellTechnomed Engineering B.V.GXY2024-05-02