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The Vertical Lift is intended to mechanically transport one person in a wheelchair or in a standing position over stairs in a private or public facility either indoors or outdoors.

Vertical Platform Lift

This is a notification of intent to market a device, it is not a study. As such, the input does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. The document is a 510(k) clearance letter for a "Vertical Lift" device, indicating that the FDA has found it substantially equivalent to previously marketed devices.

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The V-1504 Vertical Platform Lift is intended to mechanically transport an individual in a wheelchair directly between floors in a private residence or public facility.

The V-1504 Vertical Platform Lift is a a lift designed to carry a maximum of one wheelchair and two individuals (500 lb. capacity; 750 lb. optional) directly up and down between floors in a residential or public facility. It is designed for use both inside and outdoors and can be operated either enclosed or unenclosed. The V-1504 is driven by a 2:1 chain hydraulic system, consisting of two #50 high quality roller chains, a cylinder and pump powered by an electric (1.5 hp) motor. The breaking load and stress factor of each chain is 6200 lbs. The lift can be controlled from either end at a key-controlled station or from an on-board panel. All of the controls are of low voltage, incorporate continuous pressure directional buttons, and comply with U.S. ANSI/UL standard 508. The maximum lifting height is 23 feet, and the platform travels at a speed of 25 ft/min. The lift also provides for battery-powered lowering in emergency situations. The platform is constructed of ASTM A366 steel tubing and has an anti-skid surface. The enclosure is made of plexiglass and 0.100" steel tube.

The provided text describes a vertical platform lift (Savaria V-1504) and its comparison to a predicate device. However, it does not contain information about acceptance criteria for a device performance study, nor does it describe such a study.

The document is a 510(k) summary, which is a premarket submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This type of submission typically focuses on design, function, and intended use comparison rather than extensive performance studies with acceptance criteria in the way a clinical or algorithm performance study would.

Therefore, I cannot provide the requested information, particularly items 1 through 9, because the provided text does not contain a description of a study with acceptance criteria to "prove the device meets the acceptance criteria." The document discusses the device's technical specifications and compares them to a predicate device to establish substantial equivalence.

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