Apollo Air Fluidized Bed
510(k) K842987
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842987 | Date2 Aug 1984 | 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- Withdrawn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, 18 Sep 2026
The Apollo Air Fluidized Bed is an Air Fluidized Bed (Device Class II), designed for use in Physical Medicine. This device utilizes fluidized air to support and mobilize patients, reducing pressure points and promoting circulation during therapeutic interventions. It is classified under FDA regulation 890.5160 and serves as a supportive treatment aid in clinical settings.
The Apollo Air Fluidized Bed is supplied as a reusable medical device, intended for use in controlled clinical environments such as physical medicine clinics or rehabilitation centers. It operates under FDA 510(k) clearance (K842987) and is not indicated for MRI use. Available in multiple registration numbers (e.g., 3014650138, 3007420694), the device requires proper maintenance and storage per manufacturer guidelines to ensure patient safety and functionality.
Questions
AI-generated answers, 18 Sep 2026
What clinical setting is the Apollo Air Fluidized Bed primarily intended for use in, and how does it benefit patients during therapy?
The Apollo Air Fluidized Bed is designed for use in physical medicine clinics or rehabilitation centers, where it serves as a supportive treatment aid. It uses fluidized air to gently support and mobilize patients, reducing pressure points and improving circulation during therapeutic interventions. This helps prevent complications like pressure ulcers and enhances comfort during prolonged sessions.
Is the Apollo Air Fluidized Bed single-use or reusable, and what maintenance considerations should be taken into account?
The Apollo Air Fluidized Bed is a reusable medical device, meaning it is intended for repeated use in controlled clinical environments. Since it is reusable, proper maintenance and cleaning per the manufacturer’s guidelines are essential to ensure patient safety, functionality, and longevity of the device. Regular upkeep helps prevent contamination and mechanical wear.
What regulatory pathway was followed for FDA clearance of the Apollo Air Fluidized Bed, and what does this mean for its use?
The Apollo Air Fluidized Bed received FDA 510(k) clearance (K842987) through a traditional review process, determined to be *substantially equivalent* to a predicate device. This means it has met FDA standards for safety and effectiveness in its intended use—supporting patients in physical medicine settings—and is classified under FDA regulation 890.5160. The clearance does not imply MRI compatibility, so users should confirm compatibility with their specific MRI systems.
Are there multiple versions or sizes of the Apollo Air Fluidized Bed, and how would a buyer identify the correct registration number for their needs?
Yes, the Apollo Air Fluidized Bed is available in multiple registration numbers, including 3014650138, 3007420694, and others (e.g., 3002807390, 1824206). These variations may correspond to different models or configurations, though exact specifications (e.g., bed size, weight capacity) are not provided in the data. Buyers should consult the manufacturer or verify the registration number against their intended clinical application to ensure compatibility with their facility’s requirements.