21 CFR 880.5560
§ 880.5560 Temperature regulated water mattress.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 880.5560, § 880.5560 Temperature regulated water mattress, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90545
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Full text
(a) Identification. A temperature regulated water mattress is a device intended for medical purposes that consists of a mattress of suitable size, filled with water which can be heated or in some cases cooled. The device includes electrical heating and water circulating components, and an optional cooling component. The temperature control may be manual or automatic.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 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.