Walkaide 75

GUDID B3677500

Gait-enhancement electrical stimulation system, external

AXIOBIONICS

Transcutaneous electrical stimulation electrode

• Primary Device ID: B3677500
• NIH Device Record Key: b07bfab7-b258-4304-b7fa-6003219ccbaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Walkaide
• Version Model Number: 0
• Catalog Number: 75
• Company DUNS: 033139835
• Company Name: AXIOBIONICS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B3677500 [Primary]

FDA Product Code

• GZI: Stimulator, Neuromuscular, External Functional

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-06-21
• Device Publish Date: 2018-05-21

Devices Manufactured by AXIOBIONICS

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• B36711002L00 - Axio 2 Channel Stimulator: 2019-10-23 Neuromuscular Stimulator
• B3671100300 - Axio 4 Channel Stimulator: 2019-10-23 Neuromuscular Stimulator
• B36711008L00 - EMPI 300PV Stimulator: 2019-10-23 Neuromuscular Stimulator
• B36711402L00 - EMPI Continuum: 2019-10-23 Neuromuscular Stimulator
• B36712159L00 - OOFS Pace XL Stimulator: 2019-10-23 Neuromuscular Stimulator
• B367145M00 - Spectra 360 Electrode Gel: 2018-10-22 Electrode Gel Monthly Supply (4 8 oz tubes)