Duns Number:612083873
Device Description: The NYOrtho APEX Gel-Foam Cushion features an innovative design that chambers the dual gel The NYOrtho APEX Gel-Foam Cushion features an innovative design that chambers the dual gel-pod closer to the top of the cushion providing a cooler interface between the patient and wheelchair. A high-performance, stretch cover improves moisture evaporation, enhancing APEX design features.
Catalog Number
-
Brand Name
NYOrtho APEX Wheelchair Cushion Gel-Foam 18x16x3
Version/Model Number
9597-GEL-181603
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)
-
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
ef4b9782-ab17-4ec6-b7e9-4980b160b510
Public Version Date
August 22, 2022
Public Version Number
1
DI Record Publish Date
August 14, 2022
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 | 3 |