Duns Number:962525056
Device Description: The powerful and sleek Quickie® P-222 SE power wheelchair offers you the ultimate in indoo The powerful and sleek Quickie® P-222 SE power wheelchair offers you the ultimate in indoor and outdoor maneuverability and performance. Its rear-wheel drive base, sporty frame, and manual conversion kit ensure you arrive confidently and in style.
Catalog Number
EIPW2
Brand Name
Quickie P-222
Version/Model Number
P222
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
K981462
Product Code
ITI
Product Code Name
Wheelchair, Powered
Public Device Record Key
af630523-9406-440a-ac87-91639d19a69d
Public Version Date
May 11, 2021
Public Version Number
1
DI Record Publish Date
May 03, 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 |