Duns Number:533070236
Device Description: The LiteWalk pneumatic sandals [left/right] include 4 inflatable chambers that are located The LiteWalk pneumatic sandals [left/right] include 4 inflatable chambers that are located in the general regions of the heel, arch, metatarsals and toes. These chambers inflate sequentially to mimic the sequence of walking. The large size is in : US 9-11, EU 43-45. The sandals are made of Colored Fabric Material. The sandals are supplied not sterile and for a reusable single patient use.
Catalog Number
PVC0268-L
Brand Name
LiteWalk Sandals
Version/Model Number
Large
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 19, 2020
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K192607
Product Code
IRP
Product Code Name
Massager, Powered Inflatable Tube
Public Device Record Key
b94be874-5db6-4df6-af38-45fe603466ef
Public Version Date
June 29, 2020
Public Version Number
1
DI Record Publish Date
June 19, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |