Duns Number:962525056
Device Description: The JAY J2 Plus is a pre-contoured foam bariatric wheelchair cushion that offers a weight The JAY J2 Plus is a pre-contoured foam bariatric wheelchair cushion that offers a weight capacity of 650 pounds.
Catalog Number
K0669
Brand Name
Jay
Version/Model Number
J2 Plus
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
-
Product Code
IMP
Product Code Name
Cushion, Wheelchair
Public Device Record Key
b6480c5b-1563-4632-80ac-c6289033d594
Public Version Date
May 20, 2021
Public Version Number
1
DI Record Publish Date
May 12, 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 |