Data / Medical devices / Bed, Air Fluidized
Bed, Air Fluidized (INX): 6 FDA-registered makers in 4 countries
6 establishments in 4 countries are registered with the FDA to make Bed, Air Fluidized (product code INX, Class 2, 21 CFR 890.5160). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 28 510(k) clearances under this code, the latest on January 16, 1998, and lists 6 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- INX
- Device class
- 2
- Regulation
- 890.5160
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Poland | 1 |
| Japan | 1 |
| Netherlands | 1 |
Makers of Bed, Air Fluidized
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aurora Manufacturing, LLC. | Indianapolis, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ArjoHuntleigh Polska Sp. zo.o. | Poznan Wielkopolskie, Poland | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Auxilium Medical, Inc. | North Charleston, SC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hill-Rom, Inc. | Batesville, IN, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 1 | 0 | api.fda.gov | |
| Keisei Medical Industrial Co., Ltd. | BUNKYO-KU Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synergie Nederland BV | Raamsdonksveer Noord-Brabant, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 16, 1998. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.