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.

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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