Duns Number:962525056
Device Description: The QUICKIE® SR45 manual tilt wheelchair features 45° of Intelligent Rotation in Space Tec The QUICKIE® SR45 manual tilt wheelchair features 45° of Intelligent Rotation in Space Technology and a simplified mix of options for an outstanding value.
Catalog Number
EIZ9
Brand Name
Quickie SR45
Version/Model Number
SR45
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
K952641
Product Code
IOR
Product Code Name
Wheelchair, Mechanical
Public Device Record Key
a7531350-f8d3-44b0-99c1-c0fce3f679f2
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 |