Duns Number:962525056
Device Description: The JAY® J3® wheelchair back product line offers a multitude of width, height, and contour The JAY® J3® wheelchair back product line offers a multitude of width, height, and contour depth back shells to fit the back to the client. Each back is lightweight and adjustable, with numerous hardware choices allowing for easy installation. The most popular 6" contour back, PD, is now available in over 40 sizes
Catalog Number
E2613
Brand Name
Jay
Version/Model Number
J3
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
180c699e-7b12-4792-bf60-157043e7a8fd
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 |