Duns Number:962525056
Device Description: The JAY Zip is a lightweight, anti-microbial, and adjustable wheelchair back designed to p The JAY Zip is a lightweight, anti-microbial, and adjustable wheelchair back designed to provide posterior and mild lateral thoracic support for active kids!
Catalog Number
E2613
Brand Name
Jay Zip Back
Version/Model Number
Jay Zip Back
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
6c06a5bd-a122-4a9a-8976-062959fc79ff
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 |