Duns Number:178180246
Device Description: Includes MobileMat 3140 Sensor installed in floor display with 1 built in Evolution handle Includes MobileMat 3140 Sensor installed in floor display with 1 built in Evolution handle, (1) 10 ft. USB-A to USB-B cable, FootMat Software for Clinicians CD with 3140 Map, Quick Start Guide, and 1 Web-Based Training Session
Catalog Number
MMat-CLINICAL
Brand Name
Mobile Mat Evolution
Version/Model Number
MobileMat Platform FootMat with Software for Clinicians
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
54eae621-45ad-4fec-9387-ca575ad48768
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 |