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The Pacific Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only. The Pacific Bath will not be marketed for therapeutic or other medical uses.

Pacific Recumbent Height Adjustable Bath

This document is a 510(k) clearance letter from the FDA for a medical device called the "Pacific Recumbent Height Adjustable Bath." It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about acceptance criteria, device performance, ground truth, study design, or sample sizes related to the technical performance or clinical effectiveness of the device.

This type of FDA letter is primarily for regulatory clearance based on substantial equivalence to existing devices, meaning it likely relies on the established safety and performance of those predicate devices rather than requiring new, extensive performance studies with acceptance criteria as one might see for novel technologies or for specific performance claims.

Therefore, I cannot provide the requested information from this document.

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