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The Pride Mobility Products Corp. Synergy Ultimate is a power positioning seating system designed for users who need to operate their power chair and seating system independently without assistance from an attendant. The user is able to adjust the unit to achieve comfort, pressure relief, and necessary repositioning.

The Synerav Ultimate is available with any or all of the following features: Power Tilt, Power-Elevating Seat, Power Recline, and Power Elevating Leq rests. All functions can be controlled from the user's joystick, through an attendant control device, or through an optional toggle switch.

Pride Mobility Products Corp. makes no claims as to the therapeutic effectiveness of the product listed above. Pride Mobility Products Corp. strongly recommends a certified rehabilitation therapist evaluate all customers of its products.

The Synergy Ultimate is a battery-operated wheelchair seating and positioning system featuring a power tilt and / or a power seat elevator. The Synergy Ultimate is designed for, but not limited to Pride Mobility Products Corp. Powered Wheelchairs.

There are a variety of additional options available on the system including power recline with a skin shear reduction package or power articulating and elevating leg rests. Each feature can be used independently of each other or simultaneously to achieve the necessary repositioning of the user for pressure relief, increased respiratory function, positioning for daily activities or for other reasons deemed medically necessary. The frame is a welded steel construction and all materials used on the Synergy Ultimate meet or exceed the California 117 standard for Flame Resistant Testing.

The power tilt function allows the entire seat base and back to tilt rearward up to 55 degrees to transfer weight from the lower extremities to the upper torso. The power recline system allows the seat back to move independently of the seat base opening the back angle up to 170 degrees. The reclining seat back can also be equipped with a sliding back package that will limit the amount of skin sheer produced by the reclining of back. The power elevating seat function allows the client to elevate themselves up to 12 inches to gain additional access to their environment. The power elevating leg rests allow the clients lower extremeties to be elevated independently, combined or in conjunction with the Reclining Back. The elevating leg rests may also be equipped with an articulation feature that helps maintain proper knee to heel length during the elevation of the leg rests

The Synergy Ultimate has been designed with client safety as a priority. Actuator lock out and drive speed inhibits are incorporated into the system and monitored by the power seating control system to ensure client safety.

The provided text describes a 510(k) submission for the "Synergy Ultimate" power wheelchair seating system. It details the device, its intended use, and a comparison to a predicate device, as well as non-clinical testing performed.

However, the document does not contain any information regarding acceptance criteria, device performance, a specific study proving the device meets acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document states:

• "Discussion of Clinical Testing Performed: N/A"
• "Pride Mobility Products Corp. makes no claims to the therapeutic effectiveness of the product listed above."

This indicates that clinical testing was not performed for this 510(k) submission, and therefore, there is no performance data or acceptance criteria related to a clinical study to report. The submission relies solely on non-clinical testing and comparison to a predicate device to establish substantial equivalence.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details because it is not present in the provided text.

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The Geriatric Products Restraints are for use by a responsible licensed healthcare professional to limit patient movement to the extent necessary for treatment, examination, protection of patient and others, or postural control.

Protective Restraint (Models #302,440,750 and A30" x 30" Belt)

The provided document is a 510(k) premarket notification letter for a Protective Restraint device (Models #302, 440, 750, and A30" x 30" Belt) from Geriatric Products Incorporated. This type of document, particularly from 1997, does not typically contain information about objective acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment in the detailed manner that a modern regulatory submission for an AI/ML medical device would.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device's clearance was based on demonstrating substantial equivalence to a predicate device, not on meeting specific, pre-defined quantitative acceptance criteria through a formal study as would be required for a novel or high-risk device today. The substantial equivalence pathway often relies more on comparisons of technological characteristics and intended use rather than rigorous performance metric studies against acceptance criteria.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth types, training set details) from this document, as it is not present. This document is a regulatory clearance letter, not a detailed study report or performance specification document.

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