Identity
- Trade Name
- WalkAnalyst Software Kit FDA UDI
- Generic Name
- Gait-enhancement electrical stimulation system, external FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 20-0603 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858184006130 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Gait-enhancement electrical stimulation system, external
WalkAnalyst Software 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 — INNOVATIVE NEUROTRONICS INC.
- WalkAide Kit for Demo Use — INNOVATIVE NEUROTRONICS INC.
- WalkAide Kit for Japan — INNOVATIVE NEUROTRONICS INC.
- WalkAide Unit — 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 3f184751-8a04-4b5a-84ae-d6c6186c9530 35 fields · synced Jun 1, 2026