Duns Number:962525056
Device Description: The ultimate tilt-in-space wheelchair, the Quickie IRIS® Manual Tilt Wheelchair features u The ultimate tilt-in-space wheelchair, the Quickie IRIS® Manual Tilt Wheelchair features up to 55° of Intelligent Rotation in Space Technology, the broadest range of positioning and caregiver options, numerous adjustments, and it's one of the lightest tilt-in-space wheelchairs available today.
Catalog Number
EIZ4
Brand Name
Quickie IRIS
Version/Model Number
IRIS
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
IOR
Product Code Name
Wheelchair, Mechanical
Public Device Record Key
f02c499f-e09c-4347-8985-a5fe6c706a34
Public Version Date
May 12, 2021
Public Version Number
1
DI Record Publish Date
May 04, 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 |