Identity
- Trade Name
- WalkAide Kit FDA UDI
- Generic Name
- Gait-enhancement electrical stimulation system, external FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 20-1000 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858184006017 FDA UDI
- 510(k) Number
- K140886 FDA UDI
- FDA Product Code
- GZI FDA UDI
- GMDN Term
- Gait-enhancement electrical stimulation system, external FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Gait-enhancement electrical stimulation system, external
WalkAide Kit by Innovative Neurotronics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K140886 also covers:
- WalkAide Kit for Demo Use — INNOVATIVE NEUROTRONICS INC.
- WalkAide Kit for Japan — INNOVATIVE NEUROTRONICS INC.
- WalkAide Unit — INNOVATIVE NEUROTRONICS INC.
- WalkAnalyst Software Kit — INNOVATIVE NEUROTRONICS INC.
- WalkLink System ((Clinician Kit) — INNOVATIVE NEUROTRONICS INC.
- WalkLink Unit — INNOVATIVE NEUROTRONICS INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Innovative Neurotronics Inc.
Sources (1)
- FDA UDI 881b9623-2ec6-42e4-bbcb-13ba9b3542ef 36 fields · synced May 30, 2026