American Aircare System
510(k) K811684
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811684 | Date2 Jul 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FNM
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5550
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The American Aircare System is an Alternating Pressure Air Flotation Mattress, classified as a Class II medical device. It is designed to provide pressure redistribution and support for patients, particularly those at risk of pressure ulcers or requiring prolonged bed rest. The device uses alternating air cells to relieve pressure points and promote circulation, aiding in patient comfort and wound prevention in general hospital settings.
This system is intended for use in hospital environments and is supplied as a reusable device. It is regulated under FDA 510(k) clearance (K811684) with a decision of Substantially Equivalent (SESE) under regulation 880.5550. The device is not indicated for MRI use and must be stored and maintained according to manufacturer guidelines to ensure proper functionality and hygiene. No sterility claims are made, and its use is governed by standard hospital infection control protocols.
Other devices from American Hamilton
Questions
AI-generated answers, 1 Oct 2026
What is the American Aircare System used for?
The American Aircare System is an alternating pressure air flotation mattress designed to provide pressure redistribution and support for patients at risk of pressure ulcers or requiring prolonged bed rest. By cycling air through its cells, it relieves pressure points and promotes circulation, enhancing patient comfort and reducing the risk of skin breakdown in hospital settings.
Is the American Aircare System reusable or single-use?
The American Aircare System is supplied as a reusable device. It is intended for use in hospital environments and must be maintained according to manufacturer guidelines to ensure proper functionality and hygiene. Standard hospital infection control protocols apply to its reuse.
Does the American Aircare System come with any sterility claims?
No sterility claims are made for the American Aircare System. Since it is reusable, it must be cleaned and maintained following the manufacturer’s instructions to prevent contamination and ensure safe, repeated use in clinical settings.
Can the American Aircare System be used in MRI environments?
The American Aircare System is explicitly not indicated for MRI use. Patients using this device should avoid MRI procedures unless the system has been removed or confirmed safe for imaging, as air-filled components may interfere with MRI compatibility.
What regulatory approval does the American Aircare System hold?
The American Aircare System holds FDA 510(k) clearance (K811684) under regulation 880.5550, with a decision of Substantially Equivalent (SESE). This classification confirms its compliance with U.S. safety and performance standards for alternating pressure air flotation mattresses in general hospital settings.