FDA.reportPublic FDA data

Walkaide

Primary DI
B3677500
Brand
Walkaide
Company
AXIOBIONICS
Model
0
Catalog number
75
Device description
Gait-enhancement electrical stimulation system, external
Published
2018-05-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GZIStimulator, Neuromuscular, External Functional

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3677500PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
033139835
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B36711001L00EMPI Focus 2 Channel Stimulator0110012016-09-24
B36711002L00Axio 2 Channel Stimulator0110022016-09-24
B3671100300Axio 4 Channel Stimulator0110032016-09-24
B36711008L00EMPI 300PV Stimulator0110082016-09-24
B36711402L00EMPI Continuum0114022016-09-24
B36712159L00OOFS Pace XL Stimulator012159L2018-12-27
B3673350UE BioSleeve5332021-01-08
B3670030BioCollar3002016-09-24
B3670040BioCollar4002017-02-20
B3670100BioMiniVest0012016-09-24
B3670210BioVest1022016-09-24
B3670320BioUnitard2032016-09-24
B3670440BioMiniBelt4042016-09-24
B3670530BioBelt Lumbar3052016-09-24
B3670610BioBelt Lumbar Contoured1062016-09-24
B3670700BioBelt Ab0072016-09-24
B367080BioBelt Ab Large Expanded0082017-05-22
B367100M00Adhesive Electrode0100M2016-09-24
B367115P20BioGel Velcro Electrode2115P2016-09-24
B367116P20BioGel Velcro Electrode2116P2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G345SL2000CIONICCionic, Inc.GZI2026-06-04
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