510(k) K972093 ยท ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
REGENESIS MODEL 42
| Applicant | Regenesis Biomedical, Inc., Rockville MD, US |
| Decision | Substantially Equivalent, Oct 21, 1997 |
| Received | Jun 4, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972093
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2009 | Regenesis Biomedical Inc Regenesis Biomedical PROVANT Wound
Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at t Terminated |
ILX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.