Duns Number:962525056
Device Description: The Quickie® S-6 Series electric wheelchairs are built tough for serious outdoor enthusias The Quickie® S-6 Series electric wheelchairs are built tough for serious outdoor enthusiasts. Top speeds up to 8.5 mph, standard 4-pole motors, and dynamic suspension overcome tough terrain while the hybrid base maneuvers gracefully indoors. Seating options such as tilt, recline, and power elevating legrests ensure your positioning needs are met.
Catalog Number
EIS62
Brand Name
Quickie S-646
Version/Model Number
S-646
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
K010917
Product Code
ITI
Product Code Name
Wheelchair, Powered
Public Device Record Key
3af1ac85-7c9c-4467-9f6b-6d10feb57b4e
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 |