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Merits Health Products MP3 is a handicap piece of equipment and it is used to assist disabled people to negotiate their daily living. People with muscular disease use this chair to improve their daily living.

MP-3 Power Base Chair

This document is a 510(k) clearance letter from the FDA for a medical device (MP-3 Power Base Chair) and does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter confirms substantial equivalence to a predicate device and provides regulatory guidance for marketing.

Therefore, I cannot provide the requested information.

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The Merits MP-3 power base wheelchair will be used by handicapped people who are unable to ambulate. People who cannot ambulate and have weak upper body strength and cannot propel a manual wheelchair will be the ones who will benefit from the use of the MP-3 power base wheelchair.

MP-3 Power Base Chair

This document is a 510(k) clearance letter from the FDA for a power base chair (MP-3 Power Base Chair). It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any other details related to the efficacy or safety testing of the device.

The letter only states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot provide the requested information based on the input document.

Ask a specific question about this device