Duns Number:041477449
Device Description: A circular cushion of rubber and/or synthetic material which is fitted to a wheelchair whe A circular cushion of rubber and/or synthetic material which is fitted to a wheelchair wheel rim and which functions as a soft contact to the surfaces upon which the wheelchair stands and provides the wheelchair with traction and some shock absorption as it is propelled. It comes in a variety of designs, diameters and sizes. This is appropriate for spare and replacement tires.
Catalog Number
N/A
Brand Name
WHEELCHAIR TIRE
Version/Model Number
WHEELCHAIR TIRE
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KNN
Product Code Name
Components, Wheelchair
Public Device Record Key
6543608a-db5b-448a-babe-519c4c7d9457
Public Version Date
September 03, 2019
Public Version Number
1
DI Record Publish Date
August 26, 2019
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 | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 296 |