Duns Number:252468293
Device Description: The Advantage Rail Portable is a high quality, commercial grade pivoting and locking horiz The Advantage Rail Portable is a high quality, commercial grade pivoting and locking horizontal bar that connects to a floor mounted mast. The horizontal bar can be lifted, pivoted and lowered to the next locking position around the mast. The Advantage Rai Portable is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Advantage Rail Portable mast is installed to a structural floor. Inside the mast is a locking mechanism for the horizontal bar: a castellated collar with 8 grooves (every 45 degrees) to provide a mechanism strong enough to support the user. It is important to set proper height and orientation of the Advantage Rail Portable to optimize the user’s range of motion. The maximum user weight is dependent on model. Note: Product is not intended to support full body weight. The Advantage Rail Portable is not to be used in any other way than described above. The Advantage Pole Portable is a high quality, commercial grade floor mounted support pole. The Advantage Pole Portable is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Advantage Pole Portable mast is installed to a structural floor. The maximum user weight is dependent on model. Note: Product is not intended to support full body weight.
Catalog Number
00055
Brand Name
Advantage Pole™ Portable Bariatric
Version/Model Number
AR-AP-P-HD
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
IKX
Product Code Name
Aid, Transfer
Public Device Record Key
4c3a1d3b-e883-4f70-b133-99b4309f20b4
Public Version Date
September 08, 2021
Public Version Number
1
DI Record Publish Date
August 31, 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 | 298 |