Comfort Care Low Air Loss Therapy Bed
510(k) K926402
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK926402 | Date24 Mar 1993 | 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- Withdrawn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
The Comfort Care Low Air Loss Therapy Bed is an Air Fluidized Bed, classified as a Class II medical device. It is designed to reduce pressure on the patient’s body by circulating air through a fluidized matrix, thereby minimizing the risk of pressure ulcers and improving patient comfort during prolonged immobility or critical care settings.
This device is intended for use in clinical environments such as hospitals, rehabilitation centers, or long-term care facilities. Supplied as a reusable medical bed with adjustable settings, it requires proper cleaning and maintenance per manufacturer guidelines. The device holds FDA 510(k) clearance (K926402) under the Physical Medicine advisory committee and adheres to regulation 890.5160. No sterility or single-use designation is specified in the regulatory data.
Other devices from Ch Administration, Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical settings is the Comfort Care Low Air Loss Therapy Bed intended for use in?
The Comfort Care Low Air Loss Therapy Bed is designed for clinical environments such as hospitals, rehabilitation centers, and long-term care facilities. Its purpose is to reduce pressure on patients by circulating air through a fluidized matrix, helping to minimize the risk of pressure ulcers and enhance comfort during prolonged immobility or critical care situations.
Is the Comfort Care Low Air Loss Therapy Bed reusable or single-use, and how should it be maintained?
The Comfort Care Low Air Loss Therapy Bed is a reusable device. Since it is not designated as single-use or sterile, proper cleaning and maintenance per the manufacturer’s guidelines are required to ensure safe and effective use over time.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?
The Comfort Care Low Air Loss Therapy Bed received FDA clearance through a 510(k) submission, specifically under the Physical Medicine advisory committee. It was determined to be substantially equivalent to a predicate device, meaning it meets the same performance standards and regulatory requirements as previously approved air fluidized beds. This clearance allows it to be legally marketed and used in clinical settings as described.
How does the Comfort Care Low Air Loss Therapy Bed differ from standard hospital beds in terms of function?
Unlike standard hospital beds, the Comfort Care Low Air Loss Therapy Bed uses an air fluidized matrix to circulate air beneath the patient, actively reducing pressure points. This design helps prevent pressure ulcers by distributing body weight more evenly, making it ideal for patients who are critically ill, immobile, or at high risk of skin breakdown during extended bed rest.
Are there multiple models or sizes available for the Comfort Care Low Air Loss Therapy Bed?
The regulatory data lists multiple registration numbers (e.g., 3014650138, 3007420694) and FEI numbers, which typically correspond to different models or configurations of the device. While exact specifications (e.g., width, length, weight capacity) aren’t detailed in the provided data, these identifiers suggest the bed may be available in various sizes or adjustments to accommodate different patient needs in clinical settings.