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 Researchers 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
Catalog Number
MMatHR-RES
Brand Name
Mobile Mat HR VersaTek
Version/Model Number
MobileMat HR Platform with FootMat Software for Researchers
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
JFC
Product Code Name
System, Pressure Measurement, Intermittent
Public Device Record Key
45598fd3-7214-47d2-ad08-a517e64a0fe7
Public Version Date
November 19, 2020
Public Version Number
2
DI Record Publish Date
November 03, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 199 |