(174 days)
The Freedom Bed PAR 3 is used to automatically reposition immobilized persons from side to side either manually or on a programmed schedule aide in the prevention of decubitus ulcers in bed ridden patients.
The device is a programmable, automatically or manually operated repositioning bed designed for the prevention of decubitus ulcers. The device consists of 3 separate platen sections joined together with flexible hinges. The center section rotates left and right to a maximum of 30 degrees on each side, while the appropriate outer section rotates up to support and contain the sleeper. This provides a surface to transfer weight onto, as well as prevents the user from sliding or falling out of bed. The microprocessor based controller provides adjustment of time, angle and speed, as well as a choice of manual operation, automatic operation, or patient control. This allows most users to achieve independence from night time attendants and higher quality and duration of sleep. The bed has received UL 544, CSA, and FCC approvals.
This document is a 510(k) summary for a medical device (Freedom Bed™ Model PAR3) and does not contain the specific information requested regarding acceptance criteria and a study proving device performance in the context of diagnostic accuracy, AI, or expert review. The provided text is a regulatory submission for a physical medical bed designed to prevent decubitus ulcers and focuses on its description, intended use, and comparison to predicate devices, not on a performance study involving diagnostic metrics.
Therefore, I cannot provide the requested information based on the input text.
§ 890.5225 Powered patient rotation bed.
(a)
Identification. A powered patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, urinary tract blockage, and to aid circulation.(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 § 890.9.