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Walkway Evolution

FDA UDI

Class I (US FDA UDI)

by Tekscan, Inc.

Identity

Trade Name
Walkway Evolution FDA UDI
Generic Name
Body-surface pressure mapping system FDA UDI
Device Name
Includes 3 Evolution Handles, (1) 4-Port Powered USB Hub, Walkway Software CD with 5101TL Map and 3 Factory Equilibration Files, Help File and PDF of System Manual, (3) 5101 Sensors (pre-assembled into a single floor display), and 1 Training Session (USA Only) FDA UDI
Model / Reference
Very HR Walkway 3 System FDA UDI
Description
Includes 3 Evolution Handles, (1) 4-Port Powered USB Hub, Walkway Software CD with 5101TL Map and 3 Factory Equilibration Files, Help File and PDF of System Manual, (3) 5101 Sensors (pre-assembled into a single floor display), and 1 Training Session (USA Only) FDA UDI

Identifiers

Catalog Number
VH3 FDA UDI
Primary DI / UDI-DI
B970VH30 FDA UDI
FDA Product Code
JFC FDA UDI
GMDN Term
Body-surface pressure mapping system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.1600 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

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Body-surface pressure mapping system

Walkway Evolution by Tekscan, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Body-surface pressure mapping system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tekscan, Inc.

Sources (1)

  • FDA UDI e1b5845f-1e10-4a51-8ff6-92bfd580aa64 34 fields · synced Jun 1, 2026