Identity
- Trade Name
- SuperPole™ Bariatric FDA UDI
- Generic Name
- Hand rail FDA UDI
- Device Name
- The SuperPole is a high quality, commercial grade floor to ceiling safety pole. The SuperPole must be 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. NOTE: The top plate has two holes that may be used to fix the plate directly to the ceiling joist if necessary. Do not install the pole where it is directly exposed to water. Floor To Ceiling Height 93-99" / 2362-2515mm Max User Weight 450lbs / 205kgs FDA UDI
- Model / Reference
- SP-HD FDA UDI
- Description
- The SuperPole is a high quality, commercial grade floor to ceiling safety pole. The SuperPole must be 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. NOTE: The top plate has two holes that may be used to fix the plate directly to the ceiling joist if necessary. Do not install the pole where it is directly exposed to water. Floor To Ceiling Height 93-99" / 2362-2515mm Max User Weight 450lbs / 205kgs FDA UDI
Identifiers
- Catalog Number
- 01601 FDA UDI
- Primary DI / UDI-DI
- 00689281016018 FDA UDI
- FDA Product Code
- FMR FDA UDI
- GMDN Term
- Hand rail FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6785 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hand rail
SuperPole™ Bariatric by Healthcraft Products Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Healthcraft Products Inc.
Sources (1)
- FDA UDI 04e76a2e-468b-4532-b502-caca98bf5738 34 fields · synced May 30, 2026