DEVICE: Parts Box, SuperPole (00689281015332)

Device Identifier (DI) Information

Parts Box, SuperPole
SP-BX
In Commercial Distribution
01533
Healthcraft Products Inc.
00689281015332
GS1

1
252468293 *Terms of Use
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
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

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?
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.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FMR Device, Transfer, Patient, Manual
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

b8ac4827-5106-4127-a284-b9add5d59bc8
September 07, 2021
1
August 30, 2021
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE