FDA.reportPublic FDA data

WalkAide 1.25 Premium Electrodes - pkg of 4

Primary DI
00858184006109
Brand
WalkAide 1.25 Premium Electrodes - pkg of 4
Company
INNOVATIVE NEUROTRONICS, INC.
Model
20-0521
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858184006106PackageGS110In Commercial Distribution
20858184006103PackageGS114In Commercial Distribution
00858184006109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085818400610610858184006106
2085818400610320858184006103
00858184006109008581840061098581840061090858184006109

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
00858184006079WalkAide Electrodes - package of 420-05002016-08-16
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
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
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00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
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