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The Cascade Bath is intended for bathing patients and/or residents in nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only.

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This document is a 510(k) premarket notification from the FDA to Penner Manufacturing Inc. regarding their Cascade Bath Model 6900. It's a clearance letter, not a study report. Therefore, it does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

The document's purpose is to state that the FDA has reviewed Penner Manufacturing's notification and determined that the Cascade Bath Model 6900 is "substantially equivalent" to legally marketed predicate devices, allowing them to market the device.

To answer your request, information from a separate study report or regulatory submission (that would have been part of Penner Manufacturing's 510(k) submission but is not included here) would be needed.

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