(70 days)
The intended use of this product is for the healing of Decubitus Ulcers through the minimization of chronic localized occlusive pressures.
Physio / 1000 Alternating Pressure Mattress System
This document is a 510(k) clearance letter from the FDA for a device called "Physio/1000 Alternating Pressure Mattress System." It primarily addresses the regulatory approval process and does not contain detailed information on acceptance criteria or the specific studies used to demonstrate device performance.
Therefore, I cannot provide the requested information based on the provided text. The document states that the device is "substantially equivalent" to predicate devices, but it does not elaborate on the specific performance data or studies that established this equivalence.
§ 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.