FDA UDI
In Commercial Distribution
🇺🇸 United States
SuperPole™ FRS Pole
DI: 00689281005128
·
Model: FRS-P
·
Healthcraft Products Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SuperPole™ FRS Pole
- Primary DI
- 00689281005128
- Version / Model
- FRS-P
- Catalog Number
- 00512
- Company Name
- Healthcraft Products Inc.
- Labeler DUNS
- 252468293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-25
- Public Version
- 1
- Public Version Date
- 2021-09-02
- Public Version Status
- New
- Public Device Record Key
- 94ccba31-244b-421c-98fe-a6f0e77fdd48
Device 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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IKX | Aid, Transfer | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43235 | Fixed-rail armrest | A wall and/or floor fixed-rail system designed to provide arm support for a disabled person to facilitate their movement/mobility. It is permanently-fixed to the wall and/or floor at strategic points in a building or in the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00689281005128 | GS1 |