Electra-Ride III Stairway Elevator System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K970927 FDA 510(k)
- FDA Product Code
- ILK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5150 FDA 510(k)
- Regulation Number
- 890.5150 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Electra-Ride III Stairway Elevator System is a Powered Patient Transport Device designed for residential use, classified under Transport, Patient, Powered in regulatory nomenclature. It is intended for assisting individuals with limited mobility in navigating curved staircases within homes, providing safe and controlled vertical transport between floors. The system operates via a motorized rail mechanism, accommodating curved stair configurations to enhance accessibility for users who require assistance due to physical impairments.
This device is supplied as a custom-installation system, requiring professional setup tailored to the specific staircase geometry. It is not sterile and is intended for reusable residential use within a home environment. The system is FDA-cleared under 510(k) K970927 as Substantially Equivalent to a predicate device, adhering to Class II regulatory standards (regulation number 890.5150). Installation and maintenance should follow manufacturer guidelines to ensure safe operation, with no specific MRI compatibility or sterility requirements stated.
Frequently asked questions
What is the primary purpose of the Bruno Electra-Ride III Stairway Elevator System and who is it designed for?
The Bruno Electra-Ride III is a Powered Patient Transport Device specifically designed for residential use, helping individuals with limited mobility safely navigate curved staircases within their homes. It is intended for users who require assistance due to physical impairments, providing controlled vertical transport between floors without the need for sterile conditions or clinical settings.
How is the Electra-Ride III installed, and is it meant for single-use or reusable applications?
The system is supplied as a custom-installation unit, requiring professional setup tailored to the unique geometry of a home’s staircase. It is not sterile and is explicitly designed for reusable residential use within a home environment, not for clinical or medical facility applications.
Does this device have any special compatibility requirements, such as MRI safety or sterility, that a buyer should consider?
The Electra-Ride III does not require sterility for use, as it is intended for residential environments. Additionally, there are no stated MRI compatibility specifications provided in the documentation, so buyers should confirm compatibility with their specific MRI systems if needed before installation.
What regulatory pathway was followed for FDA clearance, and which medical specialty is associated with this device?
The device was cleared through the FDA 510(k) process (K970927), classified under Class II (regulation 890.5150) as *Substantially Equivalent* to a predicate device. It was reviewed by the Physical Medicine Advisory Committee (PM) and is categorized under the Transport, Patient, Powered product code (ILK).
Are there multiple models or sizes available for the Electra-Ride III, or is it a one-size-fits-all system?
The Electra-Ride III is a custom-installation system, meaning it is not sold in pre-defined sizes or models. Instead, it is tailored to the specific staircase geometry of a home, requiring professional assessment and setup to ensure proper functionality and safety.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BRUNO ELECTRA-RIDE III INSTALLATION MANUAL Pdf Download, Electra-ride III - NYC & NJ, electra ride III - Bruno Independent Living Aids - PDF Catalogs ..., PDF Bruno Electra-Ride III - Accessibility Systems
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K970927 | Class II | Active |
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Manufacturer
- Manufacturer
- Bruno Independent Living Aids, Inc.
Sources (1)
- FDA 510(k) K970927 24 fields · synced Sep 20, 2026