510(k) K843146 ยท ILO Pack, Hot Or Cold, Water Circulating
MICRO-TEMP PUMPS & MICRO-TEMP PADS
| Applicant | Seabrook Medical Systems, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Aug 17, 1984 |
| Received | Aug 10, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843146
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 19, 2015 | Cincinnati Sub-Zero Products Inc Cold Therapy Pad - cold water circulating pad, one unit per package.
The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been position Terminated |
ILO | None listed |
| Apr 6, 2005 | Cincinnati Sub-Zero Products Inc Micro-temp II heat therapy unit, model #747. Terminated |
ILO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.