Duns Number:791468734
Device Description: The WalkAide is a battery-operated, single channel electricalstimulator that is used to im The WalkAide is a battery-operated, single channel electricalstimulator that is used to improve walking ability. It stimulatesa foot lift at the correct time during walking. A foot drop occurswhen a person connot lift the foot on their own. This results in thefoot slapping on the floor or the toes dragging during walking.The WalkAide stimulates a nerve as it passes below the knee andactivates the muscles that raise the foot.The WalkAide Patient Kitincludes a WalkAide Control Unit, a WalkAide cuff, and an electrodelead cable. A foot sensor is an optional item
Catalog Number
-
Brand Name
WalkAide Kit for Demo Use
Version/Model Number
20-1002
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K140886
Product Code
GZI
Product Code Name
Stimulator, Neuromuscular, External Functional
Public Device Record Key
bfaf882b-7e5d-40cd-9853-61287aae8d1f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 16, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |