Duns Number:041477449
Device Description: Lay flat chair with tile mech, toggle hand control with USB, power headrest and lumbar sup Lay flat chair with tile mech, toggle hand control with USB, power headrest and lumbar support. This chair will have the following features as a standard option; wireless charging, USB, memory button, air bladder massage, and bluetooth capability. Available in sizes S, M, L.
Catalog Number
N/A
Brand Name
PLR4955
Version/Model Number
PLR4955
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"
Yes
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
INO
Product Code Name
Chair, Positioning, Electric
Public Device Record Key
82862055-7557-4e8f-9c8b-39c177a3eb8d
Public Version Date
August 09, 2022
Public Version Number
1
DI Record Publish Date
August 01, 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 | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 296 |