Pegasus Biwave System
510(k) K933004
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK933004 | Date7 Mar 1994 | 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- Withdrawn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, 19 Sep 2026
The Pegasus Biwave System is an alternating pressure air flotation mattress designed to support and relieve pressure on patients at risk of developing pressure ulcers. Classified as a Class II medical device, it uses sequential inflation and deflation cycles to distribute body weight and improve circulation in dependent areas.
This system is intended for use in general hospital settings and is supplied as a reusable device. It requires no sterilisation between uses and is compatible with standard hospital environments. Multiple sizes and configurations are available, as indicated by the associated FEI numbers. The device holds an FDA 510(k) clearance under product code FNM and regulation number 880.5550, with a decision date of March 7, 1994.
Other devices from Pegasus Airwave, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of patients is the Pegasus Biwave System designed to support, and where is it typically used?
The Pegasus Biwave System is designed to support patients at risk of developing pressure ulcers by distributing body weight and improving circulation in dependent areas through sequential air inflation and deflation. It is specifically intended for use in general hospital settings, making it suitable for patients who require pressure relief during prolonged bed rest or immobility.
Is the Pegasus Biwave System reusable, and if so, what cleaning or maintenance is required between uses?
Yes, the Pegasus Biwave System is a reusable device. Since it requires no sterilization between uses, standard hospital cleaning protocols—such as wiping with disinfectants compatible with air flotation mattresses—should be followed to maintain hygiene and functionality. No additional maintenance is specified beyond routine cleaning.
How do I determine the correct size or configuration for a patient, and are multiple sizes available?
Multiple sizes and configurations of the Pegasus Biwave System are available, as indicated by the associated FEI numbers in the regulatory records. To determine the correct size, measure the patient’s dimensions (e.g., length, width) and match them to the manufacturer’s sizing guidelines. The system is designed to accommodate various patient needs, ensuring proper support and pressure redistribution.
Does the Pegasus Biwave System require any special storage conditions, and how should it be stored when not in use?
The Pegasus Biwave System is designed for standard hospital environments, so no specialized storage conditions are specified. When not in use, it should be stored in a clean, dry area away from direct sunlight or extreme temperatures. Ensure the mattress is fully deflated and stored flat to prevent damage or deformation.
What regulatory pathway was followed for FDA clearance of the Pegasus Biwave System, and what does this mean for its use?
The Pegasus Biwave System holds an FDA 510(k) clearance under product code FNM and regulation number 880.5550, with a decision date of March 7, 1994. This clearance indicates the device was determined to be *substantially equivalent* to a legally marketed predicate device, meaning it meets FDA standards for safety and effectiveness as a Class II medical device. Clinicians and buyers can rely on this clearance to confirm its compliance with U.S. regulatory requirements for use in general hospital settings.