Duns Number:962525056
Device Description: Go where others can't with the Q300 M Mini: the narrowest TRUE mid-wheel drive QUICKIE pow Go where others can't with the Q300 M Mini: the narrowest TRUE mid-wheel drive QUICKIE power wheelchair with an ultra-small 17" turning radius. Enjoy a safe and comfortable ride with patented all-wheel suspension that independently cushions every wheel. Climb obstacles of up to 3" with 12" drive wheels. Power through tricky terrain with strong, energy efficient 4-pole motors. Plus, the Q300 M Mini has a multi-adjustable seating system and a whole host of styling options.
Catalog Number
EIPW40
Brand Name
Quickie Q300M
Version/Model Number
Q300M
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
34e37fb3-863c-4b89-aa8a-c5e1ee47107c
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 |