DEVICE: Parts Box, SuperPole (00689281015332)
Device Identifier (DI) Information
Parts Box, SuperPole
SP-BX
In Commercial Distribution
01533
Healthcraft Products Inc.
SP-BX
In Commercial Distribution
01533
Healthcraft Products Inc.
The SuperPole is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The SuperPole is installed between a structural floor and ceiling by turning a jackscrew at the bottom of the pole. The pressure created by the jackscrew is strong enough for the SuperPole to support the user, yet it does not require drilling holes into the floor or ceiling. This is ideal for relocating or removing the pole. The floor to ceiling range and maximum user weight dependent on model. The SuperPole is made from robust materials and is capable of supporting vigorous forces during proper / normal usage. The structural components of the pole are made from metal. The components of the pole that make direct contact with the floor and ceiling are made of non-slip rubber to protect the surfaces from damage, as well as provide traction. The top plate and base plate can be easily separated from the pole by use of multiple use fasteners (clevis and cotter pin).The top plate can be secured to the structural ceiling joist with wood screws: - if regular inspection (and if necessary, tightening) cannot be done - if pole is subjected to aggressive usage
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
b8ac4827-5106-4127-a284-b9add5d59bc8
September 07, 2021
1
August 30, 2021
September 07, 2021
1
August 30, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined