Duns Number:041477449
Device Description: A special cover worn on the hands of a wheelchair occupant designed to protect their hands A special cover worn on the hands of a wheelchair occupant designed to protect their hands when propelling wheels that are equipped with rims; this may also apply to wheelchairs that are fully- or partially-powered. The cover may be designed for different activities. This is a reusable device.
Catalog Number
N/A
Brand Name
WHEELCHAIR GLOVE
Version/Model Number
WHEELCHAIR GLOVE
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
KNO
Product Code Name
Accessories, Wheelchair
Public Device Record Key
6e5746b5-9074-45e5-aec7-b122cffd7752
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 |