Search Results

The Inclined Platform-Lift "JOURNEY" is intended to mechanically transport one person in a wheelchair or in a fold-down seat up and down stairs in a private or public facility either in indoors or outdoors.

The JOURNEY consists of a motorized main-frame with a platform, moving on a public of The JOURNET Consists of a motorized man interest man and on the discussion fixed floors in a public of piritor of a fack placed at the bottom of the blood garror, it The JOURNEY is designed to carry a private dwelling; it is an unenclosed Inclined Platformlift. The JOURNEY of wheelchair and its occupant or a person with impaired mobility seated on a folding seat. There are currently two different models designed to address different kind of staircase. - The JOURNEY (technically called RPSP) designed strictly for straight stairways. ■ - The JOURNEY (technically called TP or ) docigned for straight and turning stairways. Starways. Each of the two models is accessible via four types of platform (special size are available under Each of the two models is accessible via four types of plations (promps are raided automatically (manually in emergency cases). (fridaliy in emergency casos). The JOURNEY, as rail, uses one guide, dimensions roughly 400 mm x 65 mm, the guide is made in extruded aluminium profile (TK Ceteco drawing) and anodised. The JOURNEY CUBIC, as rail, uses two parallel guides, custom-bended according to the stainway. The JOURNEY CUBIC, as rail, uses two parallel guides, custom-bended according T The JOUNCT GODIO, as Tail, acco two paralier garabel on extruded aluminium profile (TK Ceteco drawing) and powder coated painted. The guide follows the average of staircase and is supported by specific stanchions, anchors on the steps and/or to the wall. steps and/or to the wall. The JOURNEY is equipped with an "Over-speed Governor and Safety Gear" that it is directly and THE JOURNET is equipped with an "Over operated directly by a speed limiter device with mechanically liked on the 'system of the traction system, the insettion system, the insertion of the mput menta due to the merceased specu, in caso of failers of the armanical arrest" of the platform lift. the JOURNEY is equipped with "Hold to run Buttons" and with an emergency stop button. The JOURNEY is also provided the following safety devices: - onNice is also provided the following eactly in motion towards' high on both the body and the platform; 포 - anti-scissor system in motion down under the bottom of the platform and on the bottom of the . bodv: - body, I

The provided text describes a 510(k) premarket notification for a medical device, which typically focuses on establishing substantial equivalence to a predicate device rather than presenting detailed studies with acceptance criteria and performance metrics in the way a clinical trial for a new drug or a novel, high-risk device might.

The document does not contain the information requested in points 1-9 regarding acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications for a clinical or performance study of the "JOURNEY" Inclined Platform-Lift.

Instead, the document is a regulatory communication from the FDA stating that the device is "substantially equivalent" to a legally marketed predicate device (K981486). This determination is based on the device conforming to general controls and having similar indications for use and technological characteristics to the predicate device. For devices like this, the "study" is often an engineering and safety assessment against recognized standards for inclined platform lifts, demonstrating that it meets safety requirements and performs its intended function comparably to existing, approved devices.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The submission focuses on regulatory clearance, not on presenting performance data from a specific study with defined acceptance criteria.

Ask a specific question about this device