Duns Number:041477449
Device Description: A small electrically-powered convection heater intended to be mounted on the armrest or tr A small electrically-powered convection heater intended to be mounted on the armrest or tray of a wheelchair to warm the air around the hands of the wheelchair occupant. It may be powered by a connection to a powered wheelchair and may be supplied with a cover-like device intended to be placed around the hands to restrict the area of air to be heated.
Catalog Number
N/A
Brand Name
WHEELCHAIR HAND WARMER
Version/Model Number
WHEELCHAIR HAND WARMER
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
25afc921-d86a-41d0-9776-a227178ce9b1
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 |