Duns Number:252468293
Device Description: The SuperPole is intended for moderate vertical and horizontal load bearing to provide sit The SuperPole is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The SuperPole is installed between a structural floor and ceiling by turning a jackscrew at the bottom of the pole. The pressure created by the jackscrew is strong enough for the SuperPole to support the user, yet it does not require drilling holes into the floor or ceiling. This is ideal for relocating or removing the pole. The floor to ceiling range and maximum user weight dependent on model. The SuperPole is made from robust materials and is capable of supporting vigorous forces during proper / normal usage. The structural components of the pole are made from metal. The components of the pole that make direct contact with the floor and ceiling are made of non-slip rubber to protect the surfaces from damage, as well as provide traction. The top plate and base plate can be easily separated from the pole by use of multiple use fasteners (clevis and cotter pin).The top plate can be secured to the structural ceiling joist with wood screws: - if regular inspection (and if necessary, tightening) cannot be done - if pole is subjected to aggressive usage
Catalog Number
01533
Brand Name
Parts Box, SuperPole
Version/Model Number
SP-BX
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
FMR
Product Code Name
Device, Transfer, Patient, Manual
Public Device Record Key
b8ac4827-5106-4127-a284-b9add5d59bc8
Public Version Date
September 07, 2021
Public Version Number
1
DI Record Publish Date
August 30, 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 |