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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)
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Top companies in IOQ

Company510(k)sRecalls
Baxter Healthcare Corporation017
Kinetic Concepts, Inc.57
Hill-Rom72
Hill-Rom Manufacturing, Inc.07
Bio Clinic Co.40
Support Systems Intl.40
Gsi Development Co.30
KCI USA, Inc.03
Apex Metal, Inc.20
Dermanetics Corp.20
DateFirm and productCodeLinked 510(k)
Sep 24, 2026Baxter 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
IOQNone listed
Sep 24, 2026Baxter 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
IOQNone listed
Sep 24, 2026Baxter 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
IOQNone listed
Mar 26, 2025Baxter 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
IOQK122473
Jun 14, 2024Baxter 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
IOQNone listed
Mar 29, 2024Baxter 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
IOQNone listed
Nov 2, 2023Baxter Healthcare Corporation
HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A
Open, Classified
IOQK122473
May 1, 2023Baxter 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
IOQNone listed
Jun 24, 2022Baxter Healthcare Corporation
Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.
Open, Classified
IOQNone listed
Jun 24, 2022Baxter Healthcare Corporation
Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.
Open, Classified
IOQNone listed
Jun 24, 2022Baxter Healthcare Corporation
Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.
Open, Classified
IOQNone listed
Jun 24, 2022Baxter Healthcare Corporation
Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.
Open, Classified
IOQNone listed
Jun 24, 2022Baxter Healthcare Corporation
Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.
Open, Classified
IOQNone listed
Jun 24, 2022Baxter Healthcare Corporation
Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.
Open, Classified
IOQNone listed
Jun 24, 2022Baxter 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
IOQNone listed
Feb 14, 2022Baxter Healthcare Corporation
Compella Therapy Air Supply Unit
Terminated
IOQNone listed
Feb 14, 2022Baxter Healthcare Corporation
Compella Bariatric Bed System
Terminated
IOQNone listed
Aug 13, 2018Stryker 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
IOQNone listed
Aug 9, 2013Stryker Medical Division of Stryker Corporation
IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.
Terminated
IOQNone listed
Jul 23, 2013Hill-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
IOQNone listed
Mar 14, 2013Hill-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
IOQK970636
Nov 20, 2012KCI 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
IOQNone listed
Feb 15, 2011Hill-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
IOQK863047
Feb 15, 2011Hill-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
IOQK863047
Jan 25, 2010KCI 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
IOQK944567
Jan 25, 2010KCI 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
IOQNone listed
Aug 3, 2009Hill-Rom Manufacturing, Inc.
Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.
Terminated
IOQK863047
Aug 3, 2009Hill-Rom Manufacturing, Inc.
Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores.
Terminated
IOQK863047
Oct 7, 2008Hill-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
IOQNone listed
Mar 10, 2005Kinetic Concepts, Inc
KinAir MedSurg, flotation therapy, powered hospital bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas
Terminated
IOQK970468
Jul 20, 2004Kinetic Concepts, Inc
KCI Underbed Inverter, Accessory to Powered Flotation Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX. Model number 201189
Terminated
IOQNone listed
Oct 24, 2003Hill-Rom Manufacturing, Inc.
FLEXICAIR MC3 Low Airloss Therapy unit
Terminated
IOQNone listed
Oct 24, 2003Hill-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
IOQK863047
Apr 18, 2003Kinetic Concepts, Inc
TransportAir Auxiliary Blower Unit.
Terminated
IOQNone listed
Apr 18, 2003Kinetic Concepts, Inc
PediDyne AC-Powered Adjustable Hospital Beds
Terminated
IOQNone listed
Apr 18, 2003Kinetic Concepts, Inc
BariAir AC-Powered Adjustable Hospital Beds
Terminated
IOQNone listed
Apr 18, 2003Kinetic Concepts, Inc
KinAir IV TheraPulse II AC-Powered Adjustable Hospital Beds
Terminated
IOQNone listed
Apr 18, 2003Kinetic Concepts, Inc
TriaDyne I and TriaDyne II Powered Adjustable Hospital Beds
Terminated
IOQNone listed

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