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The EMI mBath and eBath is a Product that consists of water agitators and a tub that is used in the bathing of an individual, by an attendee, in either a commercial or residential setting.

The eBath uses a microprocessor to control water filling and emptying, while the mBath uses manual gages. The eBath offers temperature monitoring, with an integrated AC powered hydraulic lift and transport chair in which an attendant can use to assist an individual. The Product is available in both 60" and 70" lengths along with an optional door and weight scale.

This document is a 510(k) clearance letter from the FDA for a medical device called the "EMI Bath." It does not contain any information about acceptance criteria, device performance testing, or studies that prove the device meets acceptance criteria.

The letter primarily states that the FDA has reviewed the premarket notification and determined the device to be substantially equivalent to legally marketed predicate devices. It lists the trade name, regulation number, regulatory class, and product code, and then outlines the general controls and regulations that the manufacturer must comply with.

Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval, not a technical report detailing performance studies.

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