Duns Number:962525056
Device Description: Quickie Q500 hybrid drive power wheelchair
Catalog Number
92282
Brand Name
Quickie Q500H Series Power Chair
Version/Model Number
5870
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 03, 2021
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ITI
Product Code Name
Wheelchair, powered
Public Device Record Key
4ea3416e-a356-4a04-8870-4bf330476f20
Public Version Date
November 30, 2021
Public Version Number
2
DI Record Publish Date
January 05, 2019
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 |