Duns Number:178180246
Device Description: Includes 1 Evolution Handle, Clinical Foot Software CD with Sensor Map, Help File and PDF Includes 1 Evolution Handle, Clinical Foot Software CD with Sensor Map, Help File and PDF of System Manual, Sensor Carrying Case, System Carrying Case, and 1 Web-Based Training Session. System includes one of the following Sensor selections: (4) 9801 Sensors -or- (2) 9830 sensors.
Catalog Number
PE1
Brand Name
Prosthetic Evolution
Version/Model Number
Prosthetic 1 (1 Handle) System
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
dc04f8b9-7f8c-4d25-a81a-da78270323c5
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 |