Identity
- Trade Name
- SuperPole™ FRS Pole FDA UDI
- Generic Name
- Fixed-rail armrest FDA UDI
- Device Name
- The SuperPole F.R.S. is a high quality, commercial grade support pole that interfaces with and is supported by a receptacle that is permanently embedded into a structural concrete floor. The SuperPole F.R.S. is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. When the pole is removed, the receptacle must be covered with a floor flush cap to provide a water-tight seal. The maximum user weight for this product is 450lbs / 205kgs. Product is not intended to support full body weight. The SuperPole F.R.S. is not to be used in any other way than described FDA UDI
- Model / Reference
- FRS-P FDA UDI
- Description
- The SuperPole F.R.S. is a high quality, commercial grade support pole that interfaces with and is supported by a receptacle that is permanently embedded into a structural concrete floor. The SuperPole F.R.S. is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. When the pole is removed, the receptacle must be covered with a floor flush cap to provide a water-tight seal. The maximum user weight for this product is 450lbs / 205kgs. Product is not intended to support full body weight. The SuperPole F.R.S. is not to be used in any other way than described FDA UDI
Identifiers
- Catalog Number
- 00512 FDA UDI
- Primary DI / UDI-DI
- 00689281005128 FDA UDI
- FDA Product Code
- IKX FDA UDI
- GMDN Term
- Fixed-rail armrest FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5050 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: Fixed-rail armrest
SuperPole™ FRS Pole by Healthcraft Products Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixed-rail armrest.
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 94ccba31-244b-421c-98fe-a6f0e77fdd48 34 fields · synced Jun 8, 2026