510(k) K863047 ยท IOQ Bed, Flotation Therapy, Powered
FLEXICAIR
| Applicant | Ssi Medical Services, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Sep 5, 1986 |
| Received | Aug 12, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863047
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | 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 | None listed |
| Aug 3, 2009 | Hill-Rom Manufacturing, Inc. Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores. 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 | 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.