21 CFR 868.5115
§ 868.5115 Device to relieve acute upper airway obstruction.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 868.5115, § 868.5115 Device to relieve acute upper airway obstruction, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89776
- Permanent ID
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Full text
(a) Identification. The device is a raised, rounded pad that, in the event of choking on a foreign body, can be applied to the abdomen and pushed upward to generate expulsion pressure to remove the obstruction to relieve acute upper airway obstruction.
(b) Classification. Class II (special controls) (“Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices”). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to § 868.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.