Microair Fluidized Air Bed
510(k) K884529
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884529 | Date18 Nov 1988 | 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- Withdrawn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 Microair Fluidized Air Bed is an Air Fluidized Bed (per FDA nomenclature), a Class II medical device designed to support patients in a low-shear environment. It uses pressurized air to create a fluidized bed that distributes body weight evenly, reducing pressure points and promoting circulation for patients with conditions such as decubitus ulcers, burns, or other pressure injuries requiring off-loading.
This device is intended for use in clinical settings such as physical medicine rehabilitation facilities, supplied as a reusable medical bed with multiple registration numbers (e.g., 3014650138, 3007420694). It is regulated under FDA regulation number 890.5160 and received FDA 510(k) clearance (K884529) in 1988 via a Traditional review pathway. No sterility or single-use designation is specified in the data.
Other devices from Gsi Development Co.
Questions
AI-generated answers, 19 Sep 2026
What types of clinical settings is the Microair Fluidized Air Bed primarily intended for, and why?
The Microair Fluidized Air Bed is designed for use in physical medicine rehabilitation facilities, where patients with conditions like decubitus ulcers, burns, or pressure injuries require off-loading. Its low-shear environment, created by pressurized air distributing body weight evenly, makes it ideal for reducing pressure points and improving circulation in these specialized settings.
Is the Microair Fluidized Air Bed single-use or reusable, and how does that affect its maintenance?
The Microair Fluidized Air Bed is reusable, as no sterility or single-use designation is specified in the data. Since it is intended for clinical use in facilities like physical medicine rehabilitation, proper cleaning and maintenance protocols must be followed to ensure hygiene and longevity, though specific cleaning instructions are not provided in the available data.
What regulatory pathway was used for FDA clearance of this device, and when was it approved?
The Microair Fluidized Air Bed received FDA 510(k) clearance (K884529) in 1988 through the Traditional review pathway. The device was deemed Substantially Equivalent (SESE) to a predicate under FDA regulation number 890.5160, with the review conducted by the Physical Medicine (PM) Advisory Committee.
Does the Microair Fluidized Air Bed come in multiple sizes or models, and how would a buyer identify them?
Yes, the Microair Fluidized Air Bed is available in multiple registration numbers, including 3014650138, 3007420694, 3002807390, 1824206, 3018070887, 3005529226, and 9611484. These identifiers correspond to different models or configurations, though specific size or feature distinctions (e.g., bed dimensions, airflow settings) are not detailed in the provided data. Buyers should verify compatibility with their facility’s needs and consult manufacturer documentation for exact specifications.