DEVICE: SuperPole™ with SuperTrapeze™ (00689281020596)
Device Identifier (DI) Information
SuperPole™ with SuperTrapeze™
STP-S
In Commercial Distribution
02059
Healthcraft Products Inc.
STP-S
In Commercial Distribution
02059
Healthcraft Products Inc.
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 SuperTrapeze handle is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. The SuperTrapeze handle is installed onto the SuperPole by securing a support arm to the pole with 3 cone point set screws. The set screws pierce into the pole and lock the support arm in place, and the spring ring is used to prevent the set screws from back-threading. The support arm has an adjustable strap that attaches to the trapeze handle. The SuperTrapeze handle is strong enough to support the user when sitting up in bed and standing. It is important to set proper height and orientation of the SuperTrapeze to optimize the user’s range of motion. The maximum user weight for this product is 300lbs / 136kgs. Note: Product is not intended to support full body weight.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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35586 | Hand rail |
A device that is fixed to the wall and is of differing bar shaped designs that is intended to provide a person with a disability a supportive hand-hold whilst standing and moving.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FMR | Device, Transfer, Patient, Manual |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
01bfa9f2-2e3c-41ec-8bb0-b00790eb0d0d
September 07, 2021
1
August 30, 2021
September 07, 2021
1
August 30, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined