Panels › General Hospital › Product code FNM · Class 2
Mattress, Air Flotation, Alternating Pressure
Regulation 880.5550
0510(k)s in 12 months (102 all time)
2recalls in 12 months (13 all time)
0recalls that name a 510(k)
Top companies in FNM
| Company | 510(k)s | Recalls |
|---|---|---|
| Kinetic Concepts, Inc. | 8 | 0 |
| Span-America Medical Systems, Inc. | 8 | 0 |
| Huntleigh Technology, Inc. | 5 | 0 |
| Hill-Rom Manufacturing, Inc. | 0 | 4 |
| 9th Wave, Inc. | 3 | 0 |
| Gaymar Industries, Inc. | 3 | 0 |
| Lumex, Inc. | 3 | 0 |
| Pegasus Airwave, Inc. | 3 | 0 |
| Plexus Medical | 3 | 0 |
| Bio Clinic Co. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2026 | Agiliti Health - Ellis Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware Open, Classified |
FNM | None listed |
| Dec 11, 2025 | Stryker Medical Division of Stryker Corporation Stryker Arise 1000EX mattress, Part Number 2236000000 Open, Classified |
FNM | None listed |
| Jun 12, 2025 | Turncare, Inc Brand Name: Guardian 2 System
Product Name: Guardian System 2 Controller
Model/Catalog Number: GS-2.5-C
Software Version: 2.5.4-69 (Fix) Open, Classified |
FNM | None listed |
| Jun 12, 2025 | Turncare, Inc Brand Name: Guardian 2 System
Product Name: Guardian System 2 Controller
Model/Catalog Number: GS-2.5-C
Software Version: 2.5.4-59 (Fix) Open, Classified |
FNM | None listed |
| Apr 15, 2021 | Getinge (Suzhou) Co Ltd Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system Terminated |
FNM | None listed |
| Jul 11, 2016 | American National Mfg Inc Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000.
Use with alternating pressure air flotation mattress. Terminated |
FNM | None listed |
| Mar 8, 2016 | Stryker Medical Division of Stryker Corporation Stryker Position Pro Mattress.
Mattress, Air Flotation, Alternating Pressure.
PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. Position Terminated |
FNM | None listed |
| May 19, 2014 | SCM True Air Technologies LLC MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc. Terminated |
FNM | None listed |
| Mar 31, 2010 | Encompass Therapeutic Support Systems dba BG North America AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn assist & on demand low air loss system; Encompass Therapuetic Support Systems, Glendale, CA.
The device is intended to trea Terminated |
FNM | None listed |
| Jan 7, 2009 | Hill-Rom Manufacturing, Inc. Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613
Designed to provide enhanced static and pulsation pressure relieving therapies. Terminated |
FNM | None listed |
| Jan 7, 2009 | Hill-Rom Manufacturing, Inc. Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361.
Designed to prevent and treat decubitus ulcers. This is accomplished by achieving interface pressures well below Terminated |
FNM | None listed |
| Jan 7, 2009 | Hill-Rom Manufacturing, Inc. Synergy Dynamic, Powered Patient Rotation Bed, Model number 5607.
Designed to provide enhanced static, pulsation and rotational pressure relieving therapies. Provides sixteen pressure zones for cust Terminated |
FNM | None listed |
| Jan 7, 2009 | Hill-Rom Manufacturing, Inc. Synergy Pulse, Powered Flotation Therapy bed, Model number 5609.
Designed to provide enhanced static and pulsation pressure relieving therapies. Provides sixteen pressure zones for customizing the s Terminated |
FNM | None listed |
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