Panels › Physical Medicine › Product code IOQ · Class 2
Bed, Flotation Therapy, Powered
Regulation 890.5170
0510(k)s in 12 months (57 all time)
3recalls in 12 months (38 all time)
10recalls that name a 510(k)
Top companies in IOQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corporation | 0 | 17 |
| Kinetic Concepts, Inc. | 5 | 7 |
| Hill-Rom | 7 | 2 |
| Hill-Rom Manufacturing, Inc. | 0 | 7 |
| Bio Clinic Co. | 4 | 0 |
| Support Systems Intl. | 4 | 0 |
| Gsi Development Co. | 3 | 0 |
| KCI USA, Inc. | 0 | 3 |
| Apex Metal, Inc. | 2 | 0 |
| Dermanetics Corp. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2026 | Baxter Healthcare Corporation PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient move Open, Classified |
IOQ | None listed |
| Sep 24, 2026 | Baxter Healthcare Corporation PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient move Open, Classified |
IOQ | None listed |
| Sep 24, 2026 | Baxter Healthcare Corporation PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a pa Open, Classified |
IOQ | None listed |
| Mar 26, 2025 | Baxter Healthcare Corporation Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S Open, Classified |
IOQ | K122473 |
| Jun 14, 2024 | Baxter Healthcare Corporation Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.Multiple model numbers of Centrella Max ma Open, Classified |
IOQ | None listed |
| Mar 29, 2024 | Baxter Healthcare Corporation Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries. Open, Classified |
IOQ | None listed |
| Nov 2, 2023 | Baxter Healthcare Corporation HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A Open, Classified |
IOQ | K122473 |
| May 1, 2023 | Baxter Healthcare Corporation Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, Open, Classified |
IOQ | None listed |
| Jun 24, 2022 | Baxter Healthcare Corporation Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04. Open, Classified |
IOQ | None listed |
| Jun 24, 2022 | Baxter Healthcare Corporation Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03. Open, Classified |
IOQ | None listed |
| Jun 24, 2022 | Baxter Healthcare Corporation Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01. Open, Classified |
IOQ | None listed |
| Jun 24, 2022 | Baxter Healthcare Corporation Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02. Open, Classified |
IOQ | None listed |
| Jun 24, 2022 | Baxter Healthcare Corporation Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01. Open, Classified |
IOQ | None listed |
| Jun 24, 2022 | Baxter Healthcare Corporation Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03. Open, Classified |
IOQ | None listed |
| Jun 24, 2022 | Baxter Healthcare Corporation Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress. Open, Classified |
IOQ | None listed |
| Feb 14, 2022 | Baxter Healthcare Corporation Compella Therapy Air Supply Unit Terminated |
IOQ | None listed |
| Feb 14, 2022 | Baxter Healthcare Corporation Compella Bariatric Bed System Terminated |
IOQ | None listed |
| Aug 13, 2018 | Stryker Medical Division of Stryker Corporation IsoFlex LAL Support Surface, Model Number 2860
Product Usage:
:
The IsoFlex LAL support surface assists in the prevention and treatment of all pressure injuries (including stages 1,2,3,4, unstageab Terminated |
IOQ | None listed |
| Aug 9, 2013 | Stryker Medical Division of Stryker Corporation IsoGel AIR 84, Support Surface.
Intended to assist in improving human patient outcomes. Terminated |
IOQ | None listed |
| Jul 23, 2013 | Hill-Rom, Inc. TotalCare Bed used with AccuMax Quantum VPC mattress
AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress
The TotalCare Bed System is intended to provide a patient support idea Terminated |
IOQ | None listed |
| Mar 14, 2013 | Hill-Rom, Inc. TotalCare SpO2RT2 bed.
Product Usage:
Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progres Terminated |
IOQ | K970636 |
| Nov 20, 2012 | KCI USA, Inc. RotoRest Delta Kinetic Therapy System
INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction Terminated |
IOQ | None listed |
| Feb 15, 2011 | Hill-Rom Manufacturing, Inc. Flexicair MC3 (Model number: M4000) Low Airloss Therapy Units
For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems an Terminated |
IOQ | K863047 |
| Feb 15, 2011 | Hill-Rom Manufacturing, Inc. Flexicair II (Model number 13000) Low Airloss Therapy Units
For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and Terminated |
IOQ | K863047 |
| Jan 25, 2010 | KCI USA, Inc. AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4102204 used with Tricell 60601 Model 212857, First Step Select Model 215200 , and Plexipulse Mod Terminated |
IOQ | K944567 |
| Jan 25, 2010 | KCI USA, Inc. AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4100079 used with Kinair IV Model 22600, Kinair IV 60601 Model 216050, Triadyne Proventa Model 40 Terminated |
IOQ | None listed |
| Aug 3, 2009 | Hill-Rom Manufacturing, Inc. Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores. Terminated |
IOQ | K863047 |
| Aug 3, 2009 | Hill-Rom Manufacturing, Inc. Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores. Terminated |
IOQ | K863047 |
| Oct 7, 2008 | Hill-Rom Manufacturing, Inc. Envision E700 Low Airloss Therapy Surface, Made By Hill-Rom Manufacturing, Inc., Charleston, SC.
The Envision E700 Low Airloss Therapy Surface helps prevent and treat stage III and stage IV pressure Terminated |
IOQ | None listed |
| Mar 10, 2005 | Kinetic Concepts, Inc KinAir MedSurg, flotation therapy, powered hospital bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas Terminated |
IOQ | K970468 |
| Jul 20, 2004 | Kinetic Concepts, Inc KCI Underbed Inverter, Accessory to Powered Flotation Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX. Model number 201189 Terminated |
IOQ | None listed |
| Oct 24, 2003 | Hill-Rom Manufacturing, Inc. FLEXICAIR MC3 Low Airloss Therapy unit Terminated |
IOQ | None listed |
| Oct 24, 2003 | Hill-Rom Manufacturing, Inc. FLEXICAIR II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR function actuators. Terminated |
IOQ | K863047 |
| Apr 18, 2003 | Kinetic Concepts, Inc TransportAir Auxiliary Blower Unit. Terminated |
IOQ | None listed |
| Apr 18, 2003 | Kinetic Concepts, Inc PediDyne AC-Powered Adjustable Hospital Beds Terminated |
IOQ | None listed |
| Apr 18, 2003 | Kinetic Concepts, Inc BariAir AC-Powered Adjustable Hospital Beds Terminated |
IOQ | None listed |
| Apr 18, 2003 | Kinetic Concepts, Inc KinAir IV TheraPulse II AC-Powered Adjustable Hospital Beds Terminated |
IOQ | None listed |
| Apr 18, 2003 | Kinetic Concepts, Inc TriaDyne I and TriaDyne II Powered Adjustable Hospital Beds Terminated |
IOQ | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.