Duns Number:252468293
Device Description: The DependaBar is a high quality, commercial grade pivoting and locking horizontal bar tha The DependaBar is a high quality, commercial grade pivoting and locking horizontal bar that connects to a wall mounted grab bar. The horizontal bar can be lifted, pivoted and lowered to the next locking position. The Dependa-Bar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Dependa-Bar is installed to a structural wall. The locking mechanism for the horizontal bar in welded to a horizontal grab 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 Dependa-Bar to optimize the user’s range of motion. The maximum user weight for this product is 325lbs / 147kgs. Note: Product is not intended to support full body weight
Catalog Number
00537
Brand Name
Dependa-Bar™, 18 in./46cm Lower Grab Rail, SS, White
Version/Model Number
DB-18-PCW
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
IKX
Product Code Name
Aid, Transfer
Public Device Record Key
32dba70b-49f2-494f-b3d9-410656138496
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
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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 |