510(k) Report

FDA applicant

Ssi Medical Services, Inc.

Chicago, IL6 decisions1986–19957 recalls

FDA records 6 decisions for Ssi Medical Services, Inc. (Chicago, IL) from 1986 to 1995: 6 510(k) clearances. Most are in product codes INX (Bed, Air Fluidized) and IXQ (Table, Radiographic, Stationary Top). 7 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Ssi Medical Services, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ssi Medical Services, Inc. since 2007.

Recalls per year

2in 2010

2009: 22010: 2
2007high 2 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ssi Medical Services, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ssi Medical Services, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • INXBed, Air Fluidized3decisions
  • IXQTable, Radiographic, Stationary Top1decision
  • IOQBed, Flotation Therapy, Powered1decision
  • FNMMattress, Air Flotation, Alternating Pressure1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K942184Clinitron at Home Air Fluided TherapySsi Medical Services, Inc. · 19951cites it
  • K863047FlexicairSsi Medical Services, Inc. · 19861cites it
  • K943385Clinitron ElexisSsi Medical Services, Inc. · 19951cites it

What has FDA decided for it lately?

  • K943385Clinitron ElexisSsi Medical Services, Inc. · 1995
  • K942184Clinitron at Home Air Fluided TherapySsi Medical Services, Inc. · 19952 recalls
  • K914351Clinitron C-10Ssi Medical Services, Inc. · 1992
  • K890523SupercairSsi Medical Services, Inc. · 1989
  • K882161Acucair Cushion Continuous Airflow SystemSsi Medical Services, Inc. · 1988
  • K863047FlexicairSsi Medical Services, Inc. · 19865 recalls

All 6 as Ssi Medical Services, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K863047Flexicair II (Model number 13000) Low Airloss Therapy Units For use to prevent pressure…Dec 6, 2010
  • K863047Flexicair MC3 (Model number: M4000) Low Airloss Therapy Units For use to prevent…Dec 6, 2010
  • K863047Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure…May 12, 2009
  • K863047Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure…May 12, 2009
  • K942184Clinitron At Home Air Fluidized Therapy BedMay 20, 2005
  • K863047FLEXICAIR II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the…Aug 27, 2003