Duns Number:252468293
Device Description: The SuperTrapeze is a high quality, commercial grade over-bed trapeze that connects to the The SuperTrapeze is a high quality, commercial grade over-bed trapeze that connects to the SuperPole (floor to ceiling safety pole). The SuperTrapeze handle features two offset ladder rungs to allow for improved use of arm strength and increased comfort. Additionally, it can hook around the pole to store out of the way when not in use. The support arm has an adjustable strap that attaches to the trapeze handle. It is important to set proper height and orientation of the SuperTrapeze to optimize the user’s range of motion.
Catalog Number
02028
Brand Name
Parts Box, SuperTrapeze
Version/Model Number
STP-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
a9ea9dc8-97c4-4ab1-8c02-2079741d4a82
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 |