21 CFR 890.5720
§ 890.5720 Water circulating hot or cold pack.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 890.5720, § 890.5720 Water circulating hot or cold pack, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91237
- Permanent ID
ys:prov:91237@1- SHA-256
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Full text
(a) Identification. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.