Duns Number:962525056
Device Description: The Quickie® Xtender® electric assist wheelchair accessory expands the range of mobility f The Quickie® Xtender® electric assist wheelchair accessory expands the range of mobility for manual wheelchair users by adding power assisted wheels to a manual frame. The Xtender increases your travel distance and propulsion efficiency and reduces overall fatigue while allowing you to maintain the look, control, and functionality of a manual wheelchair.
Catalog Number
EIXT
Brand Name
Quickie Xtender
Version/Model Number
Quickie Xtender
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
K001491
Product Code
ITI
Product Code Name
Wheelchair, Powered
Public Device Record Key
c4cc90a6-58f5-4cc0-b0ab-ad87dc4e344f
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 |