Mobile Mat HR VersaTek - Includes 1 VersaTek 2-Port Hub, Power Supply and - Tekscan, Inc.

Duns Number:178180246

Device Description: Includes 1 VersaTek 2-Port Hub, Power Supply and AC Cord, 10 ft. USB cable, (2) 10 ft. Cuf Includes 1 VersaTek 2-Port Hub, Power Supply and AC Cord, 10 ft. USB cable, (2) 10 ft. Cuff Cables, 2 built-in VersaTek Cuffs, FootMat Software for Clinicians CD with 7101E Map, Help File and PDF of System Manual, MobileMat HR 7101E Sensor installed in the MobileMat floor display, Quick Start Guide, and 1 Web-Based Training Session

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More Product Details

Catalog Number

MMatHR-CLINICAL

Brand Name

Mobile Mat HR VersaTek

Version/Model Number

MobileMat HR Platform with FootMat Software for Clinicians

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

17200d70-419f-48a7-966a-0b6108896d8d

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