Duns Number:962525056
Device Description: The JAY® GS® wheelchair cushion incorporates a highly durable, stable foam base and JAY's The JAY® GS® wheelchair cushion incorporates a highly durable, stable foam base and JAY's proven fluid insert technology with the unique ability to grow with the client while maintaining proper support, making it an excellent solution for growing children and young adults.JAY Solid Seating is a wheelchair seating accessory that provides a solid, rigid base for your properly fitted wheelchair cushion for improved positioning.
Catalog Number
E2622, E2624, E0992
Brand Name
Jay
Version/Model Number
GS, Solid Seating
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
443663f7-c239-4af9-b31c-b82c0614c8b4
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 |