MZT · Device, Heimlich Maneuver Assist
Anesthesiology · 21 CFR 868.5115 · Class 2
Overview
| Product Code | MZT |
|---|---|
| Device Name | Device, Heimlich Maneuver Assist |
| Regulation | 21 CFR 868.5115 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
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.
Classification Rationale
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.
Special Controls
*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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN000004 | QUICKAIR CHOKE RELIEVER, MODEL 59-001A | Maet Industries, Inc. | Feb 29, 2000 | DENG |
Top Applicants
- Maet Industries, Inc. — 1 clearance
