FLEXICAIR
FDA 510(k) clearance K863047 · decided 1986-09-05
Clearance details
- K-number
- K863047
- Device name
- FLEXICAIR
- Applicant
- Ssi Medical Services, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-12
- Decision date
- 1986-09-05
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- IOQ
- Device class
- 2
- Regulation number
- 890.5170
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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| FLEXICAIR EXLIPSE PLUS (K970295) | Hill-Rom, Inc. | 1997-05-16 |
| TOTAL CONTACT SEAT RIPPLE SYSTEM (K943433) | Numotech, Inc. | 1995-07-31 |
| FLEXICAIR EXLIPSE (K951001) | Hill-Rom, Inc. | 1995-06-27 |
| DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE (K945729) | Hill-Rom, Inc. | 1995-02-27 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Flexicair II (Model number 13000) Low Airloss Therapy Units For use to prevent pressure so recall (Z-1253-2011) | Hill-Rom Manufacturing, Inc. | 2011-02-15 |
| Flexicair MC3 (Model number: M4000) Low Airloss Therapy Units For use to prevent pressure recall (Z-1254-2011) | Hill-Rom Manufacturing, Inc. | 2011-02-15 |
| Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores recall (Z-1874-2009) | Hill-Rom Manufacturing, Inc. | 2009-08-03 |
| Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sore recall (Z-1875-2009) | Hill-Rom Manufacturing, Inc. | 2009-08-03 |
| FLEXICAIR II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the u recall (Z-0058-04) | Hill-Rom Manufacturing, Inc. | 2003-10-24 |