Duns Number:962525056
Device Description: The Cool Cube™ central hub input ports interface with multiple types of switches and can e The Cool Cube™ central hub input ports interface with multiple types of switches and can effectively control the various desired switch functions.The Switch-It TouchDrive2 uses proven cell phone touchscreen technology for ultra-sensitive and precise proportional driving capabilities for wheelchair control.
Catalog Number
-
Brand Name
Cool Cube / TouchDrive 2
Version/Model Number
CCB / TD2
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)
-
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
5c4cb579-1a6c-476a-ba28-dc442c1b6b41
Public Version Date
May 20, 2021
Public Version Number
1
DI Record Publish Date
May 12, 2021
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 | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |