Identity
- Trade Name
- Advantage Rail Portable: Bariatric FDA UDI
- Generic Name
- Freestanding support rail FDA UDI
- Device Name
- The Advantage Rail Portable is a high quality, commercial grade pivoting and locking horizontal bar that connects to a floor mounted mast. The horizontal bar can be lifted, pivoted and lowered to the next locking position around the mast. The Advantage Rai Portable is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Advantage Rail Portable mast is installed to a structural floor. Inside the mast is a locking mechanism for the horizontal bar: a castellated collar with 8 grooves (every 45 degrees) to provide a mechanism strong enough to support the user. It is important to set proper height and orientation of the Advantage Rail Portable to optimize the user’s range of motion. The maximum user weight is dependent on model. Note: Product is not intended to support full body weight. MAX Weight 450lbs / 205kg FDA UDI
- Model / Reference
- AR-PT-HD FDA UDI
- Description
- The Advantage Rail Portable is a high quality, commercial grade pivoting and locking horizontal bar that connects to a floor mounted mast. The horizontal bar can be lifted, pivoted and lowered to the next locking position around the mast. The Advantage Rai Portable is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Advantage Rail Portable mast is installed to a structural floor. Inside the mast is a locking mechanism for the horizontal bar: a castellated collar with 8 grooves (every 45 degrees) to provide a mechanism strong enough to support the user. It is important to set proper height and orientation of the Advantage Rail Portable to optimize the user’s range of motion. The maximum user weight is dependent on model. Note: Product is not intended to support full body weight. MAX Weight 450lbs / 205kg FDA UDI
Identifiers
- Catalog Number
- 00093 FDA UDI
- Primary DI / UDI-DI
- 00689281000932 FDA UDI
- FDA Product Code
- IKX FDA UDI
- GMDN Term
- Freestanding support rail 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: Freestanding support rail
Advantage Rail Portable: 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 6c7c169b-9c40-437f-8a74-7c2beb1cb999 34 fields · synced Jun 1, 2026