Bed, Flotation Therapy, Powered
FDA product code IOQ · Class II (moderate risk) · 21 CFR 890.5170 · Physical Medicine
57510(k) clearances
0PMA approvals
26recalls
Manufacturers
- Hill-Rom, Inc. 7
- Kinetic Concepts, Inc. 5
- Bio Clinic Co. 4
- Support Systems Intl. 4
- Gsi Development Co. 3
- Medical Flotation Systems, Inc. 2
- Dermanetics Corp. 2
- The Medical Group, Inc. 2
- Apex Metal, Inc. 2
- Western Medical, Ltd. 2
- Dermgard, Inc. 1
- Biologics Intl., Inc. 1
- Aquarius Medical Services 1
- Wholesale Medical Supply, Inc. 1
- Smi Patientcare, Inc. 1
- Air Med Assist Products 1
- Ssi Medical Services, Inc. 1
- Health Products, Inc. 1
- Hydrothermic Floatation Systems, Inc. 1
- Calm Handicap Supplies, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143414 | Hill-Rom Wireless Connectivity ModuleIOQ · Traditional | Hill-Rom | 03/10/2015SE |
| K122473 | Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2IOQ · Traditional | Hill-Rom | 06/03/2013SE |
| K973624 | Nurse's Aid Patient Rotation SystemIOQ · Traditional | Air Med Assist Products | 01/21/1998SE |
| K970364 | AIRTEC2 Low Air Loss Therapy BedIOQ · Traditional | Apex Metal, Inc. | 11/17/1997SE |
| K970363 | Hydrotec Low Air Loss Therapy BedIOQ · Traditional | Apex Metal, Inc. | 11/17/1997SE |
| K970636 | Totalcare., Modular Therapy System (MTS)IOQ · Traditional | Hill-Rom, Inc. | 08/26/1997SE |
| K964873 | Silkair Low Airloss TherapyIOQ · Traditional | Hill-Rom, Inc. | 07/03/1997SE |
| K970295 | Flexicair Exlipse PlusIOQ · Traditional | Hill-Rom, Inc. | 05/16/1997SE |
| K943433 | Total Contact Seat Ripple SystemIOQ · Traditional | Numotech, Inc. | 07/31/1995SE |
| K951001 | Flexicair ExlipseIOQ · Traditional | Hill-Rom, Inc. | 06/27/1995SE |
| K945729 | Dynamicaire(Tm) Sleep Surface, Zoneair(Tm) Sleep SurfaceIOQ · Traditional | Hill-Rom, Inc. | 02/27/1995SE |
| K941610 | Clensicair Low Airloss HydrotherapyIOQ · Traditional | Support Systems Intl. | 02/10/1995SE |
| K940662 | I-5000IOQ · Traditional | Support Systems Intl. | 06/15/1994SE |
| K931594 | Thera-Turn CM-1000 Mattress Overlay SystemIOQ · Traditional | Medical Device Inspection Co., Inc. | 12/21/1993SE |
| K932480 | PrismIOQ · Traditional | Bio Clinic Co. | 07/21/1993SE |
| K926189 | Orthoderm Consummate Air Therapy Bed W/ScaleIOQ · Traditional | Bio Clinic Co. | 06/24/1993SE |
| K926456 | Microair Turn-QIOQ · Traditional | Gsi Development Co. | 03/24/1993SE |
| K925694 | Microair PupIOQ · Traditional | Gsi Medical Systems | 03/24/1993SE |
| K923977 | Akrotech 4000IOQ · Traditional | Lumex, Inc. | 02/12/1993SE |
| K922973 | Restcue CCIOQ · Traditional | Support Systems Intl. | 07/30/1992SE |
| K922140 | Orthoderm Convertible IIIOQ · Traditional | Bio Clinic Co. | 05/27/1992SE |
| K921768 | Hazel IIIOQ · Traditional | Kinetic Concepts, Inc. | 04/29/1992SE |
| K920382 | Flexicair Low Airloss Therapy UnitIOQ · Traditional | Support Systems Intl. | 04/07/1992SE |
| K915671 | B.A.S.E. Bellows Air Support EquipmentIOQ · Traditional | Progressive Medical Technology, Inc. | 01/13/1992SE |
| K912854 | TurboIOQ · Traditional | Kinetic Concepts, Inc. | 12/20/1991SE |
| K914674 | Microair 3500IOQ · Traditional | Gsi Development Co. | 11/22/1991SE |
| K914851 | CLA-1400 SystemIOQ · Traditional | Gaymar Industries, Inc. | 11/13/1991SE |
| K912855 | HazelIOQ · Traditional | Kinetic Concepts, Inc. | 09/06/1991SE |
| K910851 | Tassi MK3 (Turnair)IOQ · Traditional | Therapy Air Support Systems, Inc. | 05/15/1991SE |
| K905126 | Comfort-AireIOQ · Traditional | Advanced Air Dynamics, Inc. | 12/19/1990SE |
| K905156 | Bio Medx Air Flotation SystemIOQ · Traditional | Bio Clinic Co. | 11/27/1990SE |
| K905053 | Stage Zero Air Flotation BedIOQ · Traditional | Lake Medical Products, Inc. | 11/26/1990SE |
| K903659 | Stage IIIIOQ · Traditional | Unique Flotation Systems, Inc. | 09/17/1990SE |
| K901890 | Mark IV Floatation Therapy BedIOQ · Traditional | Hydrothermic Floatation Systems, Inc. | 05/07/1990SE |
| K901295 | Pulmonair 40 Patient Management SystemIOQ · Traditional | The Medical Group, Inc. | 03/30/1990SE |
| K894723 | System 2500 Medical WaterbedIOQ · Traditional | Dermanetics Corp. | 08/17/1989SE |
| K894353 | Orthoderm ConvertibleIOQ · Traditional | Health Products, Inc. | 08/09/1989SE |
| K893801 | M.F.S. Low Air Loss Pulsating BedIOQ · Traditional | Medical Flotation Systems, Inc. | 07/25/1989SE |
| K893708 | Fluidized Air BedIOQ · Traditional | Gsi Development Co. | 06/22/1989SE |
| K893614 | Aeromat MRS-1000IOQ · Traditional | Integrated Therapy Products, Inc. | 06/22/1989SE |
| K890935 | System 3000 Fluidized Air BedIOQ · Traditional | Dermanetics Corp. | 03/15/1989SE |
| K882177 | Add-On to Critical Patient Care BedIOQ · Traditional | Cardio Systems, Inc. | 12/01/1988SE |
| K883192 | Smi 3000 AirbedIOQ · Traditional | Smi Patientcare, Inc. | 10/26/1988SE |
| K881843 | Pediatric Hospital BedIOQ · Traditional | The Medical Group, Inc. | 10/26/1988SE |
| K882607 | Ultraflotation BedIOQ · Traditional | Medical Flotation Systems, Inc. | 10/14/1988SE |
| K882229 | Air Bed & Flotation Dermagard 800 & 900 SystemsIOQ · Traditional | Biologics Intl., Inc. | 08/16/1988SE |
| K880486 | Dermgard System 800 and 900IOQ · Traditional | Dermgard, Inc. | 02/22/1988SE |
| K875321 | Modified Rotation Air Fluidized Bed/The TherapulseIOQ · Traditional | Kinetic Concepts, Inc. | 01/27/1988SE |
| K871614 | Decub-I-Con 800 and 900 SystemIOQ · Traditional | Wholesale Medical Supply, Inc. | 08/21/1987SE |
| K871368 | Schell C.A.P.P. Bed Model Nrs. 1268 + 1269IOQ · Traditional | Schell B.V. | 05/01/1987SE |
| K864232 | Rotation Air Fluidized Bed/DeltaIOQ · Traditional | Kinetic Concepts, Inc. | 12/16/1986SE |
| K863047 | FlexicairIOQ · Traditional | Ssi Medical Services, Inc. | 09/05/1986SE |
| K840882 | Home Care Water Flotation Bed HC4/TC/HIOQ · Traditional | Western Medical, Ltd. | 07/18/1984SE |
| K840881 | Water Floation Bed 800/TC/HIOQ · Traditional | Western Medical, Ltd. | 07/18/1984SE |
| K840697 | Calm Water Flotation Hospital BedIOQ · Traditional | Calm Handicap Supplies, Inc. | 02/27/1984SE |
| K832829 | Neo-Float Neonatal Flotation Sys & RhytIOQ · Traditional | Clinical Data Instruments, Inc. | 10/04/1983SE |
| K771264 | Flotation Therapy BedIOQ · Traditional | Aquarius Medical Services | 08/02/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1468-2025 Class II | Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other…The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing… | Baxter Healthcare Corporation | 02/25/2025Open, Classified |
| Z-2151-2024 Class II | Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments…There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper… | Baxter Healthcare Corporation | 05/08/2024Open, Classified |
| Z-1400-2024 Class II | Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient…Inconsistencies were identified with service records associated with corrections performed for a previous… | Baxter Healthcare Corporation | 03/05/2024Open, Classified |
| Z-0212-2024 Class II | HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031…Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static… | Baxter Healthcare Corporation | 10/04/2023Open, Classified |
| Z-1482-2023 Class II | Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S…There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the… | Baxter Healthcare Corporation | 03/31/2023Open, Classified |
| Z-1417-2022 Class II | Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate… | Baxter Healthcare Corporation | 06/24/2022Open, Classified |
| Z-1416-2022 Class II | Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate… | Baxter Healthcare Corporation | 06/24/2022Open, Classified |
| Z-1415-2022 Class II | Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate… | Baxter Healthcare Corporation | 06/24/2022Open, Classified |
| Z-1414-2022 Class II | Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate… | Baxter Healthcare Corporation | 06/24/2022Open, Classified |
| Z-1413-2022 Class II | Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate… | Baxter Healthcare Corporation | 06/24/2022Open, Classified |
| Z-1412-2022 Class II | Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate… | Baxter Healthcare Corporation | 06/24/2022Open, Classified |
| Z-1411-2022 Class II | Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01…The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate… | Baxter Healthcare Corporation | 06/24/2022Open, Classified |
| Z-0821-2022 Class II | Compella Therapy Air Supply UnitPotential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of… | Baxter Healthcare Corporation | 02/14/2022Terminated |
| Z-0820-2022 Class II | Compella Bariatric Bed SystemPotential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of… | Baxter Healthcare Corporation | 02/14/2022Terminated |
| Z-3181-2018 Class II | IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support…Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier. | Stryker Medical Division of Stryker… | 08/13/2018Terminated |
| Z-1946-2013 Class II | IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.Complaints were received from the field indicating that some Air Pumps were flashing and alarming when… | Stryker Medical Division of Stryker… | 07/12/2013Terminated |
| Z-1794-2013 Class II | TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress…When the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of… | Hill-Rom, Inc. | 05/30/2013Terminated |
| Z-0949-2013 Class II | TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in…In certain situations a software problem with the TotalCare SpO2RT 2 bed may occur that can lead to… | Hill-Rom, Inc. | 02/26/2013Terminated |
| Z-0409-2013 Class II | RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary…The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head… | KCI USA, Inc. | 06/27/2012Terminated |
| Z-1254-2011 | Flexicair MC3 (Model number: M4000) Low Airloss Therapy Units For use to prevent…Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to… | Hill-Rom Manufacturing, Inc. | 12/06/2010Terminated |
| Z-1253-2011 | Flexicair II (Model number 13000) Low Airloss Therapy Units For use to prevent pressure…Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to… | Hill-Rom Manufacturing, Inc. | 12/06/2010Terminated |
| Z-0663-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield…Power cords may crack and fail inside plug with potential for fire hazard. | KCI USA, Inc. | 11/04/2009Terminated |
| Z-0662-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield…Power cords may crack and fail inside plug with potential for fire hazard. | KCI USA, Inc. | 11/04/2009Terminated |
| Z-1875-2009 | Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure…The devices may emit smoke from the blower box assembly. | Hill-Rom Manufacturing, Inc. | 05/12/2009Terminated |
| Z-1874-2009 | Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure…The devices may emit smoke from the blower box assembly. | Hill-Rom Manufacturing, Inc. | 05/12/2009Terminated |
| Z-0088-2009 | Envision E700 Low Airloss Therapy Surface, Made By Hill-Rom Manufacturing, Inc.…A defect in the software of the device may not allow the patient bed exam alarm or the patient movement… | Hill-Rom Manufacturing, Inc. | 06/19/2008Terminated |