WalkAnalyst Software Kit

GUDID 00858184006130

Software used by the clinician to interface with the WalkAide unit. This allows data collection, analysis and parameter modification in order to correctly time the applied stimulation to the user.

INNOVATIVE NEUROTRONICS, INC.

Gait-enhancement electrical stimulation system, external

• Primary Device ID: 00858184006130
• NIH Device Record Key: 3f184751-8a04-4b5a-84ae-d6c6186c9530
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WalkAnalyst Software Kit
• Version Model Number: 20-0603
• Company DUNS: 791468734
• Company Name: INNOVATIVE NEUROTRONICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 888-884-6462
• Email: info@ininc.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858184006130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140886

FDA Product Code

• GZI: Stimulator, Neuromuscular, External Functional

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-16

Devices Manufactured by INNOVATIVE NEUROTRONICS, INC.

• 10858184006458 - WalkAide: 2021-02-19 WalkAide Oval Velcro Electrode, 1.5" x 3.25", 10-pack
• 20858184006455 - WalkAide: 2018-12-27 WallkAide Oval Velcro Electrode, 1.5" x 3.25", case of 14 each 10-pack
• 00858184006451 - WalkAide: 2018-12-27 WalkAide Oval Velcro Electrode, 1.5" x 3.25"
• 00858184006000 - WalkAide Unit: 2018-07-06 The WalkAide is a battery-operated, single channel electrical stimulator that is used to improve walking ability. It stimulates
• 00858184006017 - WalkAide Kit: 2018-07-06 The WalkAide is a battery-operated, single channel electrical stimulator that is used to improve walking ability. It stimulates
• 00858184006031 - WalkAide Kit for Japan: 2018-07-06 The WalkAide is a battery-operated, single channel electrical stimulator that is used to improve walking ability. It stimulates
• 00858184006048 - WalkAide Kit for Demo Use: 2018-07-06 The WalkAide is a battery-operated, single channel electrical stimulator that is used to improve walking ability. It stimulates
• 00858184006055 - WalkLink Unit: 2018-07-06 Provides a wireless connection between the WalkAide and a computer, and also allows manual stimulation during walking trials via