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The Bruno Electra-Ride™ III Stairway Elevator System, Model CRE-2100, is a Powered Patient Transport, also commonly known as a Stairway Chairlift, or Stairlift. It is a Powered Patient Transport, and is intended for medical purposes to assist transfers of patients, or mobility-impaired persons, up and down flights of stairs.

Bruno Electra-Ride™ III Stairway Elevator System

This document is a 510(k) clearance letter from the FDA for a medical device called the "Bruno Electra-Ride III Stairway Elevator System". It does not contain information about acceptance criteria or specific study data to prove the device meets performance criteria.

Therefore, I cannot extract the requested information. This type of FDA clearance letter focuses on establishing substantial equivalence to a legally marketed predicate device, not on presenting detailed performance data from a specific study against predefined acceptance criteria.

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This Product will be used by the patient to assist themselves in navigating a specific set of stairs. This is a self contained product that is mounted to the tread of a staircase. A trained dealer will install the unit, test it and teach the end user how to operate it. The typical user is someone who has limited function of their knees, hips or ankles and / or has trouble bending these joints. Other users include rehabilitated stroke victims, those inflicted with MS, arthritis, heart disease, and those who can not handle the exertion of walking up and down the stairs. The unit may be recommended by doctors or physical therapists, for those who are recuperating but a large number of users acquire a stairway elevator just because it eases the burden of climbing the stairs, improving their quality of life. For those who are wheelchair bound, it requires that they be able to transfer and is usually an option only if the physical limitations of the residence prohibits a vertical elevator.

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The provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called the "Bruno Electra-Ride™ III Stairway Elevator System". This document does not contain information about the acceptance criteria or a study proving the device meets those criteria, as requested.

The letter primarily focuses on:

• Confirming the device is substantially equivalent to legally marketed predicate devices.
• Outlining general controls provisions (annual registration, listing, good manufacturing practices, labeling, etc.).
• Indicating that the manufacturer can begin marketing the device.
• Providing contact information for regulatory questions.
• Stating the intended use of the device.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study to prove the device meets them based solely on the provided text. The document is a regulatory clearance letter, not a technical report detailing performance studies.

Ask a specific question about this device