WalkAide Kit for Japan

GUDID 00858184006031

The WalkAide is a battery-operated, single channel electrical stimulator that is used to improve walking ability. It stimulates a foot lift at the correct time during walking. A foot drop occurs when a person connot lift the foot on their own. This results in the foot slapping on the floor or the toes dragging during walking. The WalkAide stimulates a nerve as it passes below the knee and activates the muscles that raise the foot.The WalkAide Patient Kit includes a WalkAide Control Unit, a WalkAide cuff, and an electrode lead cable. A foot sensor is an optional item.

INNOVATIVE NEUROTRONICS, INC.

Gait-enhancement electrical stimulation system, external

• Primary Device ID: 00858184006031
• NIH Device Record Key: 6801a854-b7da-4596-bf9f-9a8f7cd53379
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WalkAide Kit for Japan
• Version Model Number: 21-1000
• 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: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858184006031 [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: 2018-07-06The WalkAide is a battery-operated, single channel electrical stimulator that is used to improve walking ability. It stimulates a foot lift at the correct time during walking. A foot drop occurs when a person connot lift the foot on their own. This results in the foot slapping on the floor or the toes dragging during walking. The WalkAide stimulates a nerve as it passes below the knee and activates the muscles that raise the foot.The WalkAide Patient Kit includes a WalkAide Control Unit, a WalkAide cuff, and an electrode lead cable. A foot sensor is an optional item.
• 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