Huge-Mat Evolution - Includes 2 Evolution Handles, 1 Four-Port USB - Tekscan, Inc.

Duns Number:178180246

Device Description: Includes 2 Evolution Handles, 1 Four-Port USB Hub, Research Walkway Software CD with 5400N Includes 2 Evolution Handles, 1 Four-Port USB Hub, Research Walkway Software CD with 5400ND Map, Help File and PDF of System Manual, 2 HugeMat 5400N Sensors pre-assembled into a single floor display, Neoprene Cover (12'x3'), Hub Enclosure, Wooden Shipping Crate, and 1 Training Session (USA only)

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More Product Details

Catalog Number

MXLE2

Brand Name

Huge-Mat Evolution

Version/Model Number

HugeMat Walkway 2 Evolution System

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JFC

Product Code Name

System, Pressure Measurement, Intermittent

Device Record Status

Public Device Record Key

da219775-ce35-4a79-8baf-ab17c45d045b

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

November 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TEKSCAN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 199