Home › Device types › FNM
Mattress, Air Flotation, Alternating Pressure
FDA product code FNM · Class 2 · General Hospital
3,455
Registered devices
2,524
Adverse events
13
Recalls
102
510(k) clearances
Devices with this code
PressureGuard® — SPAN-AMERICA MEDICAL SYSTEMS, INC.Auralis — Arjohuntleigh ABSelectAir Deluxe — MOXI ENTERPRISES, LLCNA — CARILEX MEDICAL, INC.The Völkner® Turning System — JAMES CONSOLIDATED, INC.K-2 KARE-ZONE — KAP MEDICALMERIDIAN MEDICAL — COMPASS HEALTH BRANDS CORP.AUTOLOGIC — Arjohuntleigh ABK-4oem AIRE-FLOAT — KAP MEDICALAUTOLOGIC — Arjohuntleigh ABMatrix — Midtown Investments, LLCSpan-America — SPAN-AMERICA MEDICAL SYSTEMS, INC.PressureGuard® — SPAN-AMERICA MEDICAL SYSTEMS, INC.K-1oem ALT-AIRE — KAP MEDICALK-4 D³X — KAP MEDICALSpan-America — SPAN-AMERICA MEDICAL SYSTEMS, INC.FOFO — Foshan Hongfeng Co., Ltd.Span-America — SPAN-AMERICA MEDICAL SYSTEMS, INC.Span-America — SPAN-AMERICA MEDICAL SYSTEMS, INC.DALTON XCELL AIR MATTRESS 2000 — DALTON MEDICAL CORPORATIONSpan-America — SPAN-AMERICA MEDICAL SYSTEMS, INC.SelectAIr — MOXI ENTERPRISES, LLCIsoAir — Tridien MedicalArroAir Pro Bariatric 14LPM Pump — ARROWHEAD HEALTHCARE SUPPLY, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-21 | Agiliti Health - Ellis | Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Managem |
| 2025-10-31 | Stryker Medical Division of Stryker Corporation | Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesti |
| 2023-11-01 | Turncare, Inc | A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running p |
| 2023-08-10 | Turncare, Inc | A software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the devi |
| 2021-04-15 | Getinge (Suzhou) Co Ltd | There is a potential for abnormal inflation of the mattress. |
| 2016-07-11 | American National Mfg Inc | The Panacea Air Pro Mattress Control Unit is being recalled due to a firmware problem, which may result in the device not having the firmness range required. |
| 2015-12-03 | Stryker Medical Division of Stryker Corporation | Potential for power cord to melt; hazards include electric shock and fire. |
| 2014-03-18 | SCM True Air Technologies LLC | The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors. |
| 2010-03-05 | Encompass Therapeutic Support Systems dba BG North America | Potential out gasing of the battery and short term ignition of the gas within the control unit enclosure. This failure mode includes a risk for fire. |
| 2008-10-09 | Hill-Rom Manufacturing, Inc. | These devices have the potential to overheat. |
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