21 CFR 880.5550
§ 880.5550 Alternating pressure air flotation mattress.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 880.5550, § 880.5550 Alternating pressure air flotation mattress, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90544
- Permanent ID
ys:prov:90544@1- SHA-256
0974509957137ae2f5d22be2c5efdaebbeac11dfd1f253566d02d1a2520f380d
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.