Duns Number:041477449
Device Description: A padded and contoured device designed to attach to the back of a wheelchair to provide th A padded and contoured device designed to attach to the back of a wheelchair to provide the wheelchair occupant with head and trunk postural support and comfort.
Catalog Number
N/A
Brand Name
PELVIC & TRUNK SUPPORT
Version/Model Number
PELVIC & TRUNK SUPPORT
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KNO
Product Code Name
Accessories, Wheelchair
Public Device Record Key
21011aae-dde4-4246-8459-f4b7ac5e36f9
Public Version Date
November 19, 2020
Public Version Number
2
DI Record Publish Date
August 26, 2019
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 | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 296 |