Duns Number:252468293
Device Description: The SuperBar is a high quality, commercial grade pivoting and locking horizontal bar that The SuperBar is a high quality, commercial grade pivoting and locking horizontal bar that connects to the SuperPole (floor to ceiling safety pole). The horizontal bar can be lifted, pivoted and lowered to the next locking position around the SuperPole. The SuperBar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The SuperBar is installed onto the SuperPole by securing a castellated collar to the pole with 3 cone point set screws. The set screws pierce into the pole and lock the collar in place, and the spring ring is used to prevent the set screws from back-threading. The castellated collar has 8 grooves (every 45 degrees) to provide a mechanism strong enough for the SuperBar to support the user. It is important to set proper height and orientation of the SuperBar to optimize the user’s range of motion. Floor To Ceiling Height 93-99" / 2362-2515mm Max User Weight 450lbs / 205kgs
Catalog Number
01496
Brand Name
Parts Box, SuperBar Heavy Duty
Version/Model Number
SPB-BXHD
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"
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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
ffda3512-5d78-4c46-9890-00ee88d28ae9
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 |