FDA.reportPublic FDA data

WalkAide Kit for Japan

Primary DI
00858184006031
Brand
WalkAide Kit for Japan
Company
INNOVATIVE NEUROTRONICS, INC.
Model
21-1000
Device description
The WalkAide is a battery-operated, single channel electricalstimulator that is used to improve walking ability. It stimulatesa foot lift at the correct time during walking. A foot drop occurswhen a person connot lift the foot on their own. This results in thefoot slapping on the floor or the toes dragging during walking.The WalkAide stimulates a nerve as it passes below the knee andactivates the muscles that raise the foot.The WalkAide Patient Kitincludes a WalkAide Control Unit, a WalkAide cuff, and an electrodelead cable. A foot sensor is an optional item.
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
GZIStimulator, Neuromuscular, External Functional

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZIStimulator, Neuromuscular, External FunctionalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140886000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140886000WALKAIDE SYSTEMInnovative Neurotronics, Inc.2014-08-08GZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858184006031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858184006031008581840060318581840060310858184006031

GMDN Terms#

Term, Definition table
TermDefinition
Gait-enhancement electrical stimulation system, externalAn assembly of devices that applies electrical stimuli to the lower extremity nerves (e.g., peroneal or femoral) or muscles (e.g., those that cause ankle dorsiflexion), to cause the muscles in the leg to contract, thus improving the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders. It typically includes electrodes and an external pulse generator (EPG), and may be incorporated into an external prosthesis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
791468734
Device count
1
Serial number
true
Manufacturing 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
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
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
06970670070242XFTShenzhen XFT Medical LimitedGZI2026-04-14
06970670070259XFTShenzhen XFT Medical LimitedGZI2026-04-14
00852184003670Motor Point Probe, Synchrony Synapse Biomedical, Inc.GZI2025-10-31
00852184003694Electrode Cable, SingleSynapse Biomedical, Inc.GZI2025-10-31
00852184003700Electrode Cable, DualSynapse Biomedical, Inc.GZI2025-10-31
00852184003717Electrode Cable, TripleSynapse Biomedical, Inc.GZI2025-10-31
00852184003724Electrode Cable, Four Synapse Biomedical, Inc.GZI2025-10-31
00852184003762Electrode Cable KitSynapse Biomedical, Inc.GZI2025-10-31
00852184003786Sensor Boot SetSynapse Biomedical, Inc.GZI2025-10-31
00852184003793Sensor Boot - SmallSynapse Biomedical, Inc.GZI2025-10-31
00852184003809Sensor Boot - MediumSynapse Biomedical, Inc.GZI2025-10-31
00852184003816Sensor Boot - LargeSynapse Biomedical, Inc.GZI2025-10-31
00852184003649Clinical Kit, SynchronySynapse Biomedical, Inc.GZI2025-10-23
00852184003656Stimulator, SynchonySynapse Biomedical, Inc.GZI2025-10-23
00852184003663Sensor, SynchonySynapse Biomedical, Inc.GZI2025-10-23
00852184003687Patient Kit, SynchronySynapse Biomedical, Inc.GZI2025-10-23
00852184003779Kit, Wireless Charger USA 5WSynapse Biomedical, Inc.GZI2025-10-23
00860011699309EvoWalkEvolution Devices, Inc.GZI2025-08-06
00810188050052L360 Thigh SystemBioness Medical, Inc.GZI2025-07-18
00810188050083L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050120L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050175L100 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050274L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050441H200 Wireless SystemBioness Medical, Inc.GZI2025-07-18
00810188050069L360 Thigh SystemBioness Medical, Inc.GZI2025-07-17
00810188050076L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050090L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050106L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050113L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050137L300 Go SystemBioness Medical, Inc.GZI2025-07-17