Duns Number:962525056
Device Description: The Quickie® Pulse® is a compact, durable power wheelchair that gives you infinite indoor The Quickie® Pulse® is a compact, durable power wheelchair that gives you infinite indoor accessibility and in-town driving capabilities. Its reliable motors, simple electronics, and seating options give you just what you need to make the most out of your day.
Catalog Number
EIPW21
Brand Name
Quickie Pulse
Version/Model Number
Pulse
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
K083249
Product Code
ITI
Product Code Name
Wheelchair, Powered
Public Device Record Key
03469dc0-37fc-454b-9d8c-4fab356b49f7
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 |