K Number
DEN000004Device Name
QUICKAIR CHOKE RELIEVER, MODEL 59-001AManufacturer
Date Cleared
2000-02-29
(32 days)
Product Code
Regulation Number
868.5115Type
Post-NSEPanel
ANReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 868.5115 Device to relieve acute upper airway obstruction.
(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.