Duns Number:252468293
Device Description: The Advantage Pole Portable is a high quality, commercial grade floor mounted support pole 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
00079
Brand Name
Advantage Rail Portable Floor Plate
Version/Model Number
AR-FP
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
a584ea88-42d0-40d4-bcc2-e6e91c79c540
Public Version Date
September 02, 2021
Public Version Number
1
DI Record Publish Date
August 25, 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 |