Mattress, Air Flotation, Alternating Pressure
FDA product code FNM · Class II (moderate risk) · 21 CFR 880.5550 · General Hospital
102510(k) clearances
0PMA approvals
13recalls
Manufacturers
- Kinetic Concepts, Inc. 8
- Span-America Medical Systems, Inc. 8
- Huntleigh Technology, Inc. 5
- Lumex, Inc. 3
- Gaymar Industries, Inc. 3
- Pegasus Airwave, Inc. 3
- 9th Wave, Inc. 3
- Plexus Medical 3
- Bio Clinic Co. 2
- Ch Administration, Inc. 2
- Micos Medical Systems 2
- Mellen Air Mfg., Inc. 2
- Medsentry Corp. 2
- Ergo-Air, Inc. 2
- Dermalex Co. 1
- George J. Kamilar 1
- Wheelchairs of Kansas 1
- Intl. Medical Equipment Corp. 1
- Hamilton Industries, Inc. 1
- Grant Airmass Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973169 | Pressure Guard Site Select (a)FNM · Traditional | Span-America Medical Systems, Inc. | 02/20/1998SE |
| K974319 | Mighty AirFNM · Traditional | Wheelchairs of Kansas | 01/22/1998SE |
| K972022 | ZAK-2000FNM · Traditional | Cardio Systems, Inc. | 01/22/1998SE |
| K974070 | PHYSIO/1000FNM · Traditional | Physio Designs, Inc. | 01/06/1998SE |
| K972549 | SimpulseFNM · Traditional | Kinetic Concepts, Inc. | 11/18/1997SE |
| K970081 | Super Air 9000 Alternating Air Floatation Mattress SystemFNM · Traditional | Cathay Consolidated, Inc. | 11/07/1997SE |
| K955243 | BariairFNM · Traditional | Kinetic Concepts, Inc. | 10/23/1997SE |
| K970468 | KT Air BedFNM · Traditional | Kinetic Concepts, Inc. | 09/05/1997SE |
| K965207 | Rid-Decube IIFNM · Traditional | Skin Care Management, Inc. | 08/21/1997SE |
| K972153 | Alternating Pressure Air Flotation MattressFNM · Traditional | Decubiti Concepts, Inc. | 07/31/1997SE |
| K971568 | Rest MattressFNM · Traditional | Rest Mattress | 07/18/1997SE |
| K954320 | Modified PedikairFNM · Traditional | Kinetic Concepts, Inc. | 07/18/1997SE |
| K970362 | Care Tec Portable Low Air Loss Therapy SystemFNM · Traditional | Apex Metal, Inc. | 05/16/1997SE |
| K970428 | Rest X SystemFNM · Traditional | Restxsys | 05/14/1997SE |
| K970350 | Equi-Pise 1000 MRSFNM · Traditional | Advanced Air Support Consultancy, Inc. | 04/22/1997SE |
| K963674 | Lumex AirFNM · Traditional | Lumex, Inc. | 01/10/1997SE |
| K963620 | 9TH Wave Models 500 & 550 Low Air Loss SystemsFNM · Traditional | 9th Wave, Inc. | 01/07/1997SE |
| K962585 | Unit-Matt 5000 Pressure Relief SystemFNM · Traditional | United Medical Equipment, Inc. | 01/07/1997SE |
| K963677 | 9TH Wave Model 200 Alternating Pressure PadFNM · Traditional | 9th Wave, Inc. | 11/26/1996SE |
| K963626 | 9TH Wave Models 400 & 450 Alternating Pressure MattressFNM · Traditional | 9th Wave, Inc. | 11/26/1996SE |
| K963510 | Aprema I - Alternating Pressure Air Flotation Mattress SystemFNM · Traditional | Mellen Air Mfg., Inc. | 11/26/1996SE |
| K961769 | Air-Medex IFNM · Traditional | Robert Gold Assoc. | 10/08/1996SE |
| K960188 | Pressureguard: SelectcareFNM · Traditional | Span-America Medical Systems, Inc. | 10/02/1996SE |
| K961854 | SPR Plus II Overlay System (CL250/CL212FNM · Traditional | Gaymar Industries, Inc. | 08/09/1996SE |
| K962123 | Akrotech 4000T Kinetic Turning Low Air Loss SystemFNM · Traditional | Lumex, Inc. | 07/18/1996SE |
| K961159 | Powered Low Air Loss Mattress SystemFNM · Traditional | Span-America Medical Systems, Inc. | 06/14/1996SE |
| K960620 | Pressureguard: Low Air Loss Mattress SystemFNM · Traditional | Span-America Medical Systems, Inc. | 04/25/1996SE |
| K961129 | Arema IIFNM · Traditional | Mellen Air Mfg., Inc. | 04/17/1996SE |
| K955874 | AltacareFNM · Traditional | Asf Industries, Inc. | 03/22/1996SE |
| K960411 | Microair by Invacare Model Apm Alternating Pressure Air Flotation MatressFNM · Traditional | Invacare Corp. | 03/18/1996SE |
| K954593 | The Aircel SystemFNM · Traditional | Marcon Group, Inc. | 02/06/1996SE |
| K954766 | Pressure Guard Alternating Pressure MattressFNM · Traditional | Span-America Medical Systems, Inc. | 01/11/1996SE |
| K953196 | Cardio-Systems Pro-OpFNM · Traditional | Ch Administration, Inc. | 11/08/1995SE |
| K953503 | Pressureguard IVFNM · Traditional | Span-America Medical Systems, Inc. | 10/24/1995SE |
| K953675 | AltadyneFNM · Traditional | Lumex, Inc. | 09/28/1995SE |
| K952610 | PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500)FNM · Traditional | Plexus Medical | 09/13/1995SE |
| K953069 | Amerimed AS110FNM · Traditional | Amerimed Systems L.C. | 08/31/1995SE |
| K952093 | Ergomat 5000 SystemFNM · Traditional | Ergo-Air, Inc. | 07/26/1995SE |
| K952092 | Ergomat 8000 SystemFNM · Traditional | Ergo-Air, Inc. | 07/26/1995SE |
| K951469 | Bazooka SystemFNM · Traditional | Innovative Medical Systems, Inc. | 06/28/1995SE |
| K950191 | The Lotecon Personal Care SystemFNM · Traditional | Lotecon, Inc. | 06/12/1995SE |
| K951112 | Pressureguard IVFNM · Traditional | Span-America Medical Systems, Inc. | 06/06/1995SE |
| K944094 | TriadyneFNM · Traditional | Kinetic Concepts, Inc. | 05/23/1995SE |
| K945845 | Micos Micropulse(Tm) or Table Patient SupportFNM · Traditional | Micos Medical Systems | 05/03/1995SE |
| K945629 | Micos Micropulse(Tm) Alternating Pressure MattressFNM · Traditional | Micos Medical Systems | 04/14/1995SE |
| K944310 | Pegasus Biwave Plus SystemFNM · Traditional | Pegasus Airwave, Inc. | 03/17/1995SE |
| K945041 | Paragon PortableFNM · Traditional | Pegabus Egerton, Ltd. | 03/16/1995SE |
| K943162 | Lake Stagezero(Tm) Air Flotation BedFNM · Traditional | Lake Medical Products, Inc. | 02/27/1995SE |
| K941083 | Dynamedics AsarFNM · Traditional | Dynamedics Corporation | 01/20/1995SE |
| K944411 | P/2000FNM · Traditional | Plexus Medical | 12/27/1994SE |
| K943097 | Circu-Flate 5000 Pressure Relief SystemFNM · Traditional | Global Medical Technologies, Inc. | 12/23/1994SE |
| K943353 | PLEXUS/1000FNM · Traditional | Plexus Medical | 12/12/1994SE |
| K942920 | Medair Excel 2000FNM · Traditional | Medifloat, Inc. | 09/19/1994SE |
| K935949 | Stryker 5000FNM · Traditional | Stryker Medical | 06/17/1994SE |
| K934817 | Surgical Design Corporation Model 700 Low Pressure MattressFNM · Traditional | Surgical Design Corp. | 06/17/1994SE |
| K933965 | Apex Medical Air PumpsFNM · Traditional | Apex Medical, Inc. | 03/17/1994SE |
| K933402 | Turbo IIFNM · Traditional | Kinetic Concepts, Inc. | 03/15/1994SE |
| K933004 | Pegasus Biwave SystemFNM · Traditional | Pegasus Airwave, Inc. | 03/07/1994SE |
| K933091 | Stage IV, CM-4000,MATTRESS Overlay SystemFNM · Traditional | Creative Medical, Inc. | 12/21/1993SE |
| K932681 | Pressureguard IVFNM · Traditional | Span-America Medical Systems, Inc. | 11/12/1993SE |
| K930673 | PremiumFNM · Traditional | Kinetic Concepts, Inc. | 08/02/1993SE |
| K926403 | PRO-2000 Low Air Loss Therapy BedFNM · Traditional | Ch Administration, Inc. | 07/30/1993SE |
| K926045 | Skytron Life Island 21FNM · Traditional | Skytron, Div. the Kmw Group, Inc. | 07/27/1993SE |
| K925651 | Life Island 21FNM · Traditional | Keisei (Usa) Co., Ltd. | 07/27/1993SE |
| K924005 | Sanken MatFNM · Traditional | Shima American Corp. | 06/17/1993SE |
| K915306 | The Kaufmann Lift-And-Turn MattressFNM · Traditional | Kaufmann Sjukvardsartiklar | 01/27/1993SE |
| K922205 | Bio Therapy PlusFNM · Traditional | Sunrise Medical, Inc. | 08/11/1992SE |
| K914775 | Talley Micro System/Talley RipplebedFNM · Traditional | Talley Group, Ltd. | 04/10/1992SE |
| K915061 | Proact CLA-1500 SystemFNM · Traditional | Clinical Systems, Inc. | 01/31/1992SE |
| K913933 | Turnsoft MattressFNM · Traditional | Turnsoft, Inc. | 01/10/1992SE |
| K901901 | Profile, a Critical Care Low Air Loss BedFNM · Traditional | Kinetic Concepts, Inc. | 10/03/1990SE |
| K901096 | Lumiscope Alternating Pressure Pad & PumpFNM · Traditional | Lumiscope Co., Inc. | 08/21/1990SE |
| K900871 | Alternating Pressure Pump and Pad SystemFNM · Traditional | Three Bears Intl. | 04/04/1990SE |
| K900131 | Bio Flote(R)FNM · Traditional | Bio Clinic Co. | 02/16/1990SE |
| K891259 | Model 4000 Alternating Pressure Pump and PadFNM · Traditional | Diamond Medical Equipment, Inc. | 11/17/1989SE |
| K891457 | Dr. Volkner's Lamellar Turning Bed(Tm)FNM · Traditional | James Consolidated, Inc. | 06/20/1989SE |
| K890012 | Huntleigh Dynamic Flotation SystemFNM · Traditional | Huntleigh Technology, Inc. | 03/29/1989SE |
| K883256 | Bio Therapy (TM) Advanced Pressure Relief SystemFNM · Traditional | Bio Clinic Co. | 10/31/1988SE |
| K882644 | Huntleigh Double Bubble AIR-O-PAD-AOP5FNM · Traditional | Huntleigh Technology, Inc. | 08/10/1988SE |
| K882092 | Clini-Care + Pressure Ulcer Treatment SystemFNM · Traditional | Gaymar Industries, Inc. | 07/13/1988SE |
| K882161 | Acucair Cushion Continuous Airflow SystemFNM · Traditional | Ssi Medical Services, Inc. | 07/12/1988SE |
| K874877 | Pegasus Airwave Syst/Spec Mattress Decubitus UlcerFNM · Traditional | Pegasus Airwave, Inc. | 02/22/1988SE |
| K874801 | Orthoderm Therapy BedFNM · Traditional | Health Products, Inc. | 02/05/1988SE |
| K871705 | Low Air Loss BedFNM · Traditional | Integrated Medical Equipment Co. | 10/09/1987SE |
| K872228 | Pharmaseal Alternating Pressure Pad SystemFNM · Traditional | American Pharmaseal Div. Ahsc | 09/04/1987SE |
| K870681 | Huntleigh Beta II HM85FNM · Traditional | Huntleigh Technology, Inc. | 03/04/1987SE |
| K863152 | Medsentry Flotation SystemFNM · Traditional | Medsentry Corp. | 09/23/1986SE |
| K850419 | Auto TurnerFNM · Traditional | George J. Kamilar | 05/21/1985SE |
| K844499 | Medsentry Softouch SystemFNM · Traditional | Medsentry Corp. | 01/30/1985SE |
| K844880 | Huntleigh Air-O-Pad AOP1 Alternating Press-MattresFNM · Traditional | Huntleigh Technology, Inc. | 01/25/1985SE |
| K844879 | Huntleigh Alphacare, HM95 Alternating Press-PumpFNM · Traditional | Huntleigh Technology, Inc. | 01/25/1985SE |
| K833964 | Pegasus MattressFNM · Traditional | Dermalex Co. | 01/30/1984SE |
| K813407 | Air MattressFNM · Traditional | Trans World Agency, Inc. | 12/31/1981SE |
| K811684 | American Aircare SystemFNM · Traditional | American Hamilton | 07/02/1981SE |
| K803307 | Mattress, Air Floatation, Altern. Press.FNM · Traditional | Intl. Medical Equipment Corp. | 01/13/1981SE |
| K800231 | Abco/Grant Alternating Pressure Pad & UtFNM · Traditional | Abco Dealers, Inc. | 02/26/1980SE |
| K792001 | Comficare Pad (for Singel PT Use)FNM · Traditional | Hamilton Industries, Inc. | 10/26/1979SE |
| K781404 | Bed Pads: D-12 and D-8FNM · Traditional | Grant Airmass Corp. | 09/07/1978SE |
| K780906 | Air-Flo Alternating Pressure Pad SystemFNM · Traditional | Gaymar Industries, Inc. | 08/10/1978SE |
| K780502 | Nova Air Floatation SystemFNM · Traditional | Nova Health Systems, Inc. | 04/10/1978SE |
| K771463 | Aero Pulse Alternating Pres. PumpFNM · Traditional | Medline Industries, Inc. | 08/26/1977SE |
| K761012 | Alphabed Alternating Pressure PadFNM · Traditional | Nlowtron-Aire , Ltd. | 12/09/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1472-2026 Class II | Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support…Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support… | Agiliti Health - Ellis | 01/21/2026Open, Classified |
| Z-0919-2026 Class II | Stryker Arise 1000EX mattress, Part Number 2236000000Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these… | Stryker Medical Division of Stryker… | 10/31/2025Open, Classified |
| Z-1967-2025 Class II | Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog…A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in… | Turncare, Inc | 11/01/2023Open, Classified |
| Z-1968-2025 Class II | Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog…A software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen… | Turncare, Inc | 08/10/2023Open, Classified |
| Z-1788-2021 Class II | Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay systemThere is a potential for abnormal inflation of the mattress. | Getinge (Suzhou) Co Ltd | 04/15/2021Terminated |
| Z-2605-2016 Class II | Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use…The Panacea Air Pro Mattress Control Unit is being recalled due to a firmware problem, which may result in… | American National Mfg Inc | 07/11/2016Terminated |
| Z-1081-2016 Class II | Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure.…Potential for power cord to melt; hazards include electric shock and fire. | Stryker Medical Division of Stryker… | 12/03/2015Terminated |
| Z-1632-2014 Class II | MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and… | SCM True Air Technologies LLC | 03/18/2014Terminated |
| Z-1216-2010 | AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn assist & on…Potential out gasing of the battery and short term ignition of the gas within the control unit enclosure.… | Encompass Therapeutic Support Systems dba… | 03/05/2010Terminated |
| Z-0603-2009 | Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613 Designed to…These devices have the potential to overheat. | Hill-Rom Manufacturing, Inc. | 10/09/2008Terminated |
| Z-0602-2009 | Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361.…These devices have the potential to overheat. | Hill-Rom Manufacturing, Inc. | 10/09/2008Terminated |
| Z-0601-2009 | Synergy Dynamic, Powered Patient Rotation Bed, Model number 5607. Designed to provide…These devices have the potential to overheat. | Hill-Rom Manufacturing, Inc. | 10/09/2008Terminated |
| Z-0600-2009 | Synergy Pulse, Powered Flotation Therapy bed, Model number 5609. Designed to provide…These devices have the potential to overheat. | Hill-Rom Manufacturing, Inc. | 10/09/2008Terminated |