Duns Number:962525056
Device Description: The new QUICKIE Q500 M power wheelchair balances superb indoor maneuverability with outsta The new QUICKIE Q500 M power wheelchair balances superb indoor maneuverability with outstanding performance and head-turning style. All of these combined with the benefits of the highly configurable SEDEO PRO seating and the most advanced controls, creates the perfect power wheelchair for any adventure.
Catalog Number
EIPW30
Brand Name
Quickie Q500/Q400 Series
Version/Model Number
Q500/Q400
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
K060531
Product Code
ITI
Product Code Name
Wheelchair, Powered
Public Device Record Key
3548f459-629c-4bf6-b3d5-5f149fe4b7e1
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 |