Stage IV Air-Fluidize Bed
by Unique Flotation Systems, Inc.
510(k) K904008
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904008 | Date10 Oct 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- INX
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5160
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is an Air Fluidized Bed, classified as a Class II medical device under FDA regulation 890.5160. It employs a fluidized air system to support patients, reducing pressure points and promoting circulation, primarily for use in physical medicine settings. The air-fluidized bed consists of silicone-coated ceramic beads through which filtered air circulates, creating a fluid-like support surface to alleviate pressure-related injuries.
The Stage IV Air-Fluidize Bed is supplied as a reusable device and is intended for use in clinical environments such as hospitals or rehabilitation centers. It is not sterile upon delivery and requires cleaning and maintenance as specified by the manufacturer. The device is authorized under FDA 510(k) clearance (K904008) and falls under the Physical Medicine specialty category. Multiple registration numbers (e.g., 3014650138, 3007420694) correspond to its regulatory filings.
Other devices from Unique Flotation Systems, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Stage IV Air-Fluidize Bed in clinical settings?
The Stage IV Air-Fluidize Bed is designed to support patients by using a fluidized air system of silicone-coated ceramic beads, reducing pressure points and improving circulation. This makes it particularly useful in preventing pressure-related injuries, such as bed sores, in patients who require extended bed rest, commonly found in hospitals or rehabilitation centers.
Is the Stage IV Air-Fluidize Bed intended for single-use or can it be reused?
The Stage IV Air-Fluidize Bed is a reusable device, meaning it is not meant for single-use. However, it is not sterile upon delivery and must be cleaned and maintained according to the manufacturer’s instructions to ensure proper functionality and hygiene in clinical environments.
How is the regulatory status of this device determined, and what does that mean for buyers?
The Stage IV Air-Fluidize Bed holds FDA 510(k) clearance under the classification of a Class II medical device (regulation number 890.5160) and is deemed *substantially equivalent* to a predicate device. This means it has undergone review by the FDA’s Physical Medicine advisory committee and meets established safety and effectiveness standards for use in physical medicine settings, ensuring it complies with U.S. regulatory requirements.
What types of clinical environments is this device most suitable for, and why?
This device is most suitable for clinical environments like hospitals, rehabilitation centers, or long-term care facilities where patients require extended bed rest or have limited mobility. Its design—using a fluidized air system to distribute pressure evenly—helps prevent pressure ulcers and supports patients with conditions requiring specialized support surfaces.
How should the Stage IV Air-Fluidize Bed be stored when not in use?
While the manufacturer’s specific storage instructions aren’t detailed in the provided data, reusable medical devices like this typically require protection from dust, moisture, and physical damage. The device should be stored in a clean, dry environment, following the manufacturer’s maintenance guidelines to preserve its silicone-coated ceramic beads and air filtration system for optimal performance.