Duns Number:962525056
Device Description: Quickie IRIS Manual Wheelchair
Catalog Number
ElZ4-2
Brand Name
Quickie® Series Manual Wheelchair
Version/Model Number
ElZ4-2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 03, 2021
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"
Yes
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
6fe47976-b25d-4756-ba0e-638fe9b29003
Public Version Date
November 30, 2021
Public Version Number
3
DI Record Publish Date
August 23, 2016
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 |