MatScan Evolution - Includes 1 Evolution Handle, FootMat Software for - Tekscan, Inc.

Duns Number:178180246

Device Description: Includes 1 Evolution Handle, FootMat Software for Clinicians CD with Huge-Mat Map, Help Fi Includes 1 Evolution Handle, FootMat Software for Clinicians CD with Huge-Mat Map, Help File and PDF of System Manual, MatScan XL 5400N Sensor installed in floor display, Quick Start Guide, and 1 Web-Based Training Session

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More Product Details

Catalog Number

MXLE1

Brand Name

MatScan Evolution

Version/Model Number

MatScan XL 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

87207c2c-ca49-46b0-bbee-31af69478f67

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