Duns Number:962525056
Device Description: The JAY J2 Series wheelchair backs are designed to provide posterior and lateral pelvic st The JAY J2 Series wheelchair backs are designed to provide posterior and lateral pelvic stability along with enhanced trunk support.The JAY J2 pre-contoured foam wheelchair cushions feature a JAY Flow™ fluid tripad with up to 3" of loading for superior skin protection and support.
Catalog Number
E2613, #2620, E2622, E2623, E2624, E2625
Brand Name
Jay
Version/Model Number
J2
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
ba4a8cd4-806a-4c13-90f7-4a815c3c6b30
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 |