Duns Number:252468293
Device Description: The e2 Ceiling Mount Trapeze is an over-bed trapeze system that secures to the ceiling. Th The e2 Ceiling Mount Trapeze is an over-bed trapeze system that secures to the ceiling. The trapeze handle features two offset ladder rungs to allow for improved use of arm strength and increased comfort. Additionally, it can slide sideward / laterally on the ceiling mounted grab bar to store out of the way when not in use. The e2 Ceiling Mount Trapeze is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. The grab bar is installed to a structural ceiling, and a metal hook is looped onto the grab bar. The trapeze handle is connected with an adjustable strap to the metal hook. The maximum user weight for this product is 300lbs / 136kgs. No more than 150lbs / 68kgs is to be exerted on the e2 trapeze (sitting support only). NOTE: Product is not intended to support full body weight.
Catalog Number
01045
Brand Name
e2™ Ceiling Mount Trapeze with 32 in. Grab Bar
Version/Model Number
STP-CM-32
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
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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
789a3e6b-6c21-4dc4-a56b-b247464541cf
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 |