Duns Number:028456795
Device Description: The Zeno Electronic Walkway with PKMAS Software deliver Gait Analysis measurements that de The Zeno Electronic Walkway with PKMAS Software deliver Gait Analysis measurements that describe the performance, style, effectiveness and efficiency of walking without referring to its etiology.
Catalog Number
Z418-220 ALL SIZES
Brand Name
ZENO ELECTRONIC WALKWAY
Version/Model Number
Platinum
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
Yes
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
8146c533-1e42-4900-854d-8bac76dae0fa
Public Version Date
October 15, 2021
Public Version Number
2
DI Record Publish Date
February 08, 2021
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 | 1 |