(80 days)
The REST Mattress is indicated for all patients highly susceptible to decubitus ulcers. The REST Mattress provides alternating pressure support for the prevention and management of these sores.
REST Mattress
The provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called "REST Mattress". It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria, device performance data, study design, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies. It is a regulatory approval letter, not a clinical study report.
Therefore, I cannot provide the requested information based on the input text.
§ 880.5550 Alternating pressure air flotation mattress.
(a)
Identification. An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.